a prescription for better medicine: why canadians need a ... · a prescription for better medicine:...

A Prescription for Better Medicine: Why Canadians need a national

pharmacare program

Acknowledgements

This report was researched and written by Michael Butler, Health Care Campaigner, The Council of Canadians.

A Prescription for Better Medicine: Why Canadians need a national pharmacare program is published under the Creative Commons licence Attribution-NonCommercial-ShareAlike 4.0.

A Prescription for Better Medicine: Why Canadians need a national pharmacare program 3

TABLE OF CONTENTS

Introduction ..................................................................................................................................... 4

An unfinished story .......................................................................................................................... 4

The changing landscape of prescription drug costs ......................................................................... 5

The new Big Pharma reality ............................................................................................................. 5

Our fragmented system is failing Canadians ................................................................................... 7

Trading away our health .................................................................................................................. 9

A better model, better medicine .................................................................................................. 12

Canadians are dying because they cannot afford their medication ............................................... 13

A national formulary: evidence, safety, appropriatenesss, value for money ................................. 13

Big Pharma’s influence on public health professionals .................................................................. 15

Flawed clinical trials: we need better evidence ............................................................................. 17

Enhanced price controls ................................................................................................................ 18

Health Canada and Big Pharma ...................................................................................................... 19

Canadians call for pharmacare ....................................................................................................... 21

There is no better time than now .................................................................................................. 22

Endnotes ........................................................................................................................................ 23


INTRODUCTION

In modern health care, appropriately used prescription drugs are an essen-tial component to health and well-be-ing. The World Health Organization (WHO) has declared that all nations should ensure universal access to nec-essary medicines through pharmaceu-tical policies that work in conjunction with broader systems of universal health coverage.1 The gaps in our cur-rent system exacerbate inequalities rather than prevent them, as “Cana-da’s health care system is not the uni-versal equalizer we like to think it is.”2

We regularly hear stories of big phar-maceutical companies – “Big Pharma”

– increasing prices on lifesaving medi-cations and patients suffering the con-sequences of this unfettered greed. It is time to bring Canada’s drug cover-age into the 21st century and ensure drug coverage for everyone – a system that puts people before profit. Cana-dians across the country know that a universal, national drug coverage plan – also known as pharmacare – is long overdue. It is time for the federal gov-ernment to carry out Tommy Douglas’ vision of equitable, safe and effective drug coverage for everyone.

The discussion over a national phar-macare program is inspired not only by

the important cost savings a program would bring, but by the need to actu-alize the right to universal health care for everyone in Canada. This funda-mental cornerstone of our medicare, which values need over ability to pay, is still as important today as it was over a decade ago. No one should have to choose between buying food for their family, paying rent or getting the med-ications they need. All Canadians de-serve equal access to safe and effective medically necessary drugs. It is time to finish writing the final chapter in medi-care’s story.

AN UNFINISHED STORY

Canada has the unique distinction of being the only country with a univer-sal national public health care plan not to include prescription drug coverage. Beginning in the post-war years of the 1940s, many similar countries intro-duced national drug plans into their health care systems to address the inadequate drug coverage for their cit-izens. In these countries, three gener-ations have now benefited from their governments implementing phar-macare. Meanwhile, Canadians con-tinue to pay increasing prices and have less access to the medications they need.

A national drug coverage plan was first recommended in Canada by the Royal Commission on Health Services in 1964. It was known as the “Hall Commission” after its chair, former Saskatchewan Supreme Court Justice Emmett Hall. Justice Hall argued that, “in view of the high cost of many of the new life saving, life sustaining, pain kill-ing, and disease preventing medicines, prescribed drugs should be introduced

as a benefit of the public health ser-vices program.”3 Yet, to this day, phar-macare remains one of the core pieces missing from our medicare system.

Since then, there have been multiple recommendations that consistently call for universal drug coverage – from the National Health Forum under Jean Chrétien in 1997 to the Romanow Com-mission in 2002.4 The Romanow Com-mission made the specific recommen-dation that all governments in Canada work together to integrate medically necessary medication into the Canada Health Act, which would create nation-al standards for universal access. Im-portantly it “specifically recommended that a National Drug Agency be created to coordinate a wide range of pharma-ceutical policies, including evaluating new drugs, negotiating drug prices and coverage decisions, monitoring of drug safety and electiveness, and providing information to patients.”5 Yet despite the ever-increasing evidence and calls for policy changes, little progress has

been made to establish universal phar-macare for Canadians.

Medicine used in acute care at hos-pitals is 100 per cent publicly cov-ered in accordance with the Canada Health Act, but there are no national standards for coverage of prescription drugs outside of hospitals in Canada. The federal government has jurisdic-tional responsibility for regulating pharmaceutical products, regulating pharmaceutical marketing and setting intellectual property rights and relat-ed policies that affect the availability, price and use of medicines. Since the provinces bear the majority of the re-sulting costs from federal policy, there is often friction between the two levels of government.6

The fact that health policy reformers at both levels of government, health care advocates and the public continue to put forward the idea of universal phar-macare shows there is strong passion for better and more equitable medi-care in Canada. It shows that we will not give up on a good idea.7


THE CHANGING LANDSCAPE OF PRESCRIPTION DRUG COSTS

The health landscape in Canada is changing. Prior to the 1980s:

Prescription medication costs made up a relatively small proportion of health care spending. The 1980s marked a period of rapid growth for the pharmaceutical sector, owing to multiple factors such as scientific and technological advances in pharmacology; changes in population size, demographic characteristics, and health status; and shifts in patent laws and innovations in the marketing of pharmaceuti-cal products.8

It is worth noting that since 2010, Ca-nadian provinces have been working together in a group called the Pan-Ca-nadian Pharmaceutical Alliance to low-er drug costs through a bulk buying initiative. Since March 2015 there have been 63 completed joint negotiations

on brand name drugs and price reduc-tions on 14 generic drugs, leading to $490 million in combined savings an-nually.9 While this may seem substan-tial, it is only the tip of the iceberg for possible savings.

The facts surrounding the current situ-ation are clear. Prescription and retail drugs have now become one of the top three largest contributors to health ex-penditures in Canada.10 Total spending on prescription drugs has nearly qua-drupled since the 1990s, of which 42 per cent is financed by the public sec-tor and 23 per cent is paid out of pock-et by patients. The per capita cost of prescription medications has increased fivefold since 1984.11 In 2016, Canadi-ans will fill over 600 million prescrip-tions at a cost of more than $30 bil-lion.12 This amount is four times more than what we spent on prescriptions 20 years ago. No other component of Canadian health care has increased in cost as quickly.13

THE NEW BIG PHARMA REALITY

It seems that every other month there is a major story from south of the bor-der about price gouging and preda-tory tradecraft by Big Pharma. In one example, Martin Shkreli and the drug company Turing raised the price of py-rimethamine, an old medication used to treat a parasitic infection in the brains of immune-compromised (usu-ally HIV-infected) people from $13.50 to $750 a pill – an increase of over 5,000 per cent.14 In another, Health Bresch and drug company Mylan raised the price of the EpiPen auto-in-jector to more than $600 for two pens right before the start of a new school year when parents were buying new EpiPens for their school-bound chil-dren.15 There is about $1 worth of the

hormone epinephrine in each EpiPen. Through price hikes EpiPen is “becom-ing a $1 billion-a-year product that clobbers its rivals and provides about 40 per cent of Mylan’s operating prof-its.”16 This vulgar capitalism is the in-dustry playbook, and these companies are not just fringe actors.

The result is that the pharmaceutical sector accounts for a significant por-tion of government health budgets, with a fifth of the entire health care budget of Organisation for Econom-ic Co-operation and Development (OECD) countries spent on medicines. The amount spent globally on medi-cines is “forecasted to grow at a com-pound annual rate of 4-7 percent over

the next five years and will reach a to-tal of $1.3 trillion by 2018.”17

Pharmaceutical companies’ profits outpace other industries. In 2010, Big Pharma’s profits were three times higher than those of the other Fortune 500 companies combined.18 In the first quarter of 2016, more than two-thirds of the 20 biggest pharmaceutical com-panies used price hikes to drive large revenue growth.19

For example, sales of AbbVie’s anti-in-flammatory drug humira rose 32 per cent to $2.2 billion for the first quar-ter.20 Over the last five years in the United States, the top 10 best selling drugs each went up in price by at least 50 per cent. Johnson & Johnson in-

In 2016, Canadians will fill over 600 million prescriptions at a cost of more than $30 billion.


creased the list price on its anti-inflam-matory medication remicade, used for auto-immune disorders, by 63 per cent, while Amgen’s list price on en-brel more than doubled.21 Cancer drug prices have also increased dramatical-ly. A $10,000-a-month cancer drug has become the new normal in the U.S. The average monthly amount insurers and patients paid for a new cancer drug was less than $2,000 in the year 2000, but soared to $11,325 in 2014.22,23 In Ontario alone, expenditures for can-cer drugs – both intravenous and oral – was $652 million in 2014-15, an in-crease of 20 per cent over the previous year.24

Sofosbuvir, a hepatitis C drug manufac-tured by Gilead Sciences, represented an important breakthrough for pa-tients, with cure rates of more than 90 per cent during a three month treat-ment. This medication could possibly eliminate hepatitis C, which is a lead-ing infectious killer globally. It primar-ily affects vulnerable groups, such as people who inject drugs or have HIV/AIDS.25 It has a list price in the U.S. of close to $100,000. For Canadians, the cost related to the direct-acting antivi-rals (DAAs) for the treatment of hep-atitis C has become a critical issue for public plans, private insurers and pa-tients. By the second quarter of 2015, sales exceeded $182 million in just over a two-year period.26 In Canada and abroad this has meant that very few patients who would benefit from these drugs can access them, espe-cially those in vulnerable groups who are most in need. The high price tag for DAAs has little to do with the cost of manufacturing them. Instead, the price results from what is called the drug-pricing trap.

Economists estimate that the average mark-up for patented drugs is nearly 400 per cent in the U.S.27 Many other needed medications have also seen

huge price hikes in the U.S. The aver-age price of insulin for diabetes, for ex-ample, jumped 300 per cent between 2002 and 2013. The price for heart drug isoproterenol is up 2,500 per cent, and the cost of blood pressure drug digoxin has risen 637 per cent.28

Unlike most other industries, Big Phar-ma’s ability to raise prices year after year continues unfettered.29 As Doctors Without Borders has noted, “The price of Novartis’s gleevec (imatinib) for leukaemia has risen three-fold in the past decade; Biogen raised the price of a treatment for multiple sclerosis an average of 16 per cent a year in the ten years since 2005, with 21 separate price hikes. On January 1, 2016, Pfizer arbitrarily raised the price on over 100 drugs in the US. Price hikes are a strat-egy that allows companies to maintain revenues even in the absence of suc-cessful, innovative products.”30 This is the reality when market forces, red in tooth and claw, decide how accessible medicines should be.

Canada is not insulated from the issues plaguing American health care. After two decades of inaction, and various approaches to managing medication costs, Canada has some of the highest drug prices in the world. No matter how you measure it, Canadians pay more for medication than they should because we lack bargaining power in a fragmented system. Take the block-buster cholesterol drug lipitor, for ex-ample. A year’s supply of the brand-name drug in Canada costs at least $811; in New Zealand, where a public authority negotiates drug prices on be-half of the entire country, a year’s sup-ply of the brand name costs just $15.31

Overall, it has been shown that the prices of generic drugs in Canada are 79 per cent higher than the median of prices found in other OECD countries. The prices of brand name drugs in

Canada are roughly 30 per cent higher than in comparable countries like the United Kingdom.32 Looking at per capi-ta pharmaceutical expenditures, Cana-da’s are higher than all other OECD na-tions, with the exception of the United States. Alternatively, if drug prices in Canada were brought down to the OECD average, the savings would be approximately $9.6 billion annually.33 Bringing per capita drug spending in line with spending in the United King-dom, which performs better than the OECD average, would not only provide Canadians with better access to medi-cations, it would also save $14 billion annually.34

Since 2000, federal government data shows that the increases in drug ex-penditures in Canada have outpaced increases in all other countries. Ca-nadian drug expenditures overall in-creased by 184.43 per cent between 2000 and 2012, a rate higher than any other comparator country, even the United States.35 In 2013, Canadians spent 1.8 per cent of our Gross Domes-tic Product (GDP) on pharmaceuticals. Canadians spent $29 billion in 2015 on prescription drugs – which equals $814 a year per Canadian, according to the Canadian Institute for Health Infor-mation.36 For patented drug products, sales increased in 2015 to $15.2 billion from $13.8 billion in 2014, an increase of 9.5 per cent. This was the largest single increase in Canadian history of patented drug sales. In 2014, patented drug products accounted for 61.8 per cent of the total drug sales in Cana-da, an increase from 59.9 per cent in 2014.37

Canada’s generic drug prices are also exceptionally high. There is almost a 20 per cent gap between generic drug prices in Canada and those in foreign markets.38 The problem rests in the


fact that instead of bargaining for a lower price:

Provinces pay an arbitrary per-centage of the price charged by the company that, many years before, first marketed the drug that the generic is copying. For example, if the original drug is $1 per pill, Ontario’s Minis-try of Health and Long Term Care usually aims to pays 25 per cent (so 25 cents) for the generic version. Different prov-inces use different percentages, but all are locked into this basic system, as are private health insurers or individual Canadi-ans.39

As a result of this, in 2010, Canadian prices were 40 per cent higher than in France, Germany, Italy, Sweden, Switzerland, the United Kingdom, the United States, the Netherlands, Spain, Australia, and New Zealand.40 With ge-neric prescription drug sales totaling $5.4 billion annually, Canadians are being price gouged between $1 billion and $1.67 billion.41 A universal phar-

macare program would increase Cana-dians’ bargaining power substantially and garner the best discounts through a competitive bidding process.

There is also an increase in the con-centration of Big Pharma companies in Canada due to mergers and acquisi-tions. Four pharmaceutical companies account for more than 65 per cent of all revenues in nine out of 10 of the largest pharmaceutical subgroups.42 The pharmaceutical industry is con-centrated in Ontario, Quebec and British Columbia, and these provinces received 94 per cent of venture capital in 2008. The poorest provinces, includ-ing Newfoundland and Labrador, New Brunswick and Prince Edward Island, received virtually no spinoff benefits from the pharmaceutical sector de-spite paying the same high prices as the rest of Canada.43

Despite Big Pharma’s record breaking profits in recent years, spending on pharmaceutical research and develop-ment (R&D) in Canada has hit historic lows. In 2014, drug companies (specif-ically pantentees) spent 4.4 per cent

of earnings on R&D, which is the low-est amount since reporting started in 1988.44 In 1987, pharmaceutical com-panies promised to increase their in-vestment in R&D to an amount equiv-alent to 10 per cent of their domestic sales in return for increasing their pe-riods of market exclusivity. This is the 12th consecutive year in a row that Canadian pharmaceutical companies have not met the 10 per cent thresh-old. It is a myth that subsidies and in-creased patent rights are needed to entice Big Pharma to conduct R&D. Research shows that public financial subsidies to attract pharmaceutical sector R&D investments are often greater than the total R&D spending of drug companies in Canada.45 There is no economic justification for Cana-dians to pay an extra $10.2 billion to generate only $9.6 billion.46 While drug companies like to talk about the “free market,” the government grants them forms of patent rights, exclusivi-ty for their drugs, and so on. What Big Pharma is interested in are customers, not cures.

OUR FRAGMENTED SYSTEM IS FAILING CANADIANS

Our current fragmented system means higher drug costs for everyone and huge profits for Big Pharma. Canada has a total of 19 publicly funded drug plans (10 provincial, three territorial and six federal). Eligibility, coverage and benefit payment schemes vary in each of these programs. Your postal code or socio-economic status should not dictate if you receive necessary medication, but in some provinces only people on social assistance, seniors or those suffering from certain diseases are covered, while in other provinces people are covered based on an in-come assessment. For example, in On-tario bunion removal and IVF services

are insured, but insulin for diabetes is not. A study tracking 600,000 patients in Ontario with diabetes found that “roughly 830 young and middle-aged patients are dying each year from want of access to something as basic as insulin – a product that we can be so truly very proud of given its discovery in Canada by Banting & Best and the award of the [Nobel] prize in 1923.”47

Of all other OECD countries, only the United States and Poland have a low-er percentage of drug costs paid for by public programs (Canada is also second only to the United States in the use of private insurance).48 It is im-portant to note that for many of these

plans people must pay a portion of the drug costs (co-pays), which creates a proven obstacle to acquiring needed medications. The fact that a person with “$20,000 out-of-hospital drug cancer treatment will pay nothing out-of-pocket in Nunavut, $3,000 in British Columbia and $20,000 in Prince Ed-ward Island offends the principles of medicare and Canadian values.”49There is also an issue with unequal access to medication for Canadians with private plans between provinces. With varying coverage and payment schemes be-tween jurisdictions, beneficiaries end up paying more or less for access to es-sential medicines depending on where


they live, not on the basis of medical need.50 For example, in Ontario, analy-sis shows that just 38 per cent of work-based private plans covered 100 per cent of the cost of drugs.51 Overall, it is estimated that individuals end up paying 22 per cent of all drug costs in Canada out of pocket.52 It is important to note that number excludes employ-ees’ contributions to work-based pre-miums as well as people who buy indi-vidual insurance plans, so the figure is likely higher.

Private plans miss the mark on their estimates of chronic disease in the workplace. For example, “59 per cent of employees have at least one chronic condition – high blood pressure, high cholesterol and depression are the most common – plan sponsors think just 32 per cent do.”53 For older work-ers, 79 per cent of employees aged 55 to 64 have at least one condition. Chronic disease is a serious issue in Canada, accounting for 67 per cent of all health care costs. For younger work-ers, three out of five Canadians older than age 20 have a chronic disease, while four out of five are at risk of de-veloping one.54

Many specialized medicines can cost $50,000 or even $500,000 per patient per year.55 While the cost of mainte-nance drugs (for example, drugs to control blood pressure) has risen 58 per cent since 2005, biologics and spe-cialty drugs have increased by 325 per cent in that same time.56 Higher-cost specialty drugs are expected to ac-count for 35 per cent of spending by 2018 (up from a prediction of 27 per cent in 2014).57 Private drug plan pro-viders have realized that our current system is not sustainable in the long term and are passing on more costs to beneficiaries. Recent data from the insurance industry shows that 83 per cent of private drug plan sponsors find the new drugs coming to market are

too expensive for their plans to remain sustainable, and 90 per cent of respon-dents agree with shifting costs on to benefit plan recipients.58 Currently, at least 30 per cent of private plans now have maximums on drug coverage, which is leading Canadians to an Amer-ican model where medication is held back from patients who require it.59

Alternatively, a universal pharmacare plan would save the private sector $8.2 billion annually and provide high qual-ity, equitable coverage to everyone.60

It is estimated that 10 million Cana-dians are covered by publicly funded drug plans – 9 million through pro-vincial plans and an additional million through federal plans.61 Conversely, more than two-thirds of Canadians – close to 25 million – do not have ac-cess to a public drug plan. The large majority of Canadians – around 71 per cent – are forced to obtain drug cov-erage through private insurers, either through their employers or purchased individually.62 In a nation that prides itself on humanity, this means that 10 per cent of Canadians – around 3.5 mil-lion people – lack even basic drug cov-erage.63 In some provinces, like British Columbia, approximately 19 per cent of the population has no drug cover-age.64 Data from Ontario suggests that:

One-quarter of people who did not have prescription medica-tion insurance most often fell into certain groups including: people with the lowest level of education, recent immigrants, and people living in the poor-est neighbourhoods.... Among those aged 12 to 64 in Ontario, 53 per cent more people living in the richest neighbourhoods had prescription medication insurance, at 85.7per cent, compared to people living in the poorest neighbourhoods, where 56 per cent had it.65

Canadians working low-income jobs are cruelly one of the worst off in our system, as they generally do not have drug coverage as part of their employ-ment, but they earn “too much” to be covered under public plans. Near-ly all employees earning more than $100,000 receive health benefits (94 per cent), compared to 32 per cent of those earning between $10,000 and $20,000 and 17 per cent of those earning $10,000 or less.66 Men are also more likely to have a benefits plan from their employer than women be-cause women work more often in part-time jobs that do not offer health ben-efits.67,68 Only 1 in 4 part time workers have employer-provided health ben-efits. For workers aged 25 and under, again, only 1 in 4 have employer-pro-vided benefits. This comes at a time when approximately 39 per cent of workers between the ages of 15 and 29 are precariously employed.69 A recent survey found that nearly 50 per cent of respondents say they rely on each pay-cheque to cover their bills, with 40 per

More than two-thirds of Canadians – close to 25 million – do not have access to a public drug plan.


cent admitting they spend an amount equal to all or more of their net pay each week. Twenty-five per cent stat-ed they wouldn’t be able to come up with $2,000 if an emergency situation happened within the next month.70 It is no surprise then that studies show that 1 in 3 Canadians with incomes under $50,000 reported that they or someone in their house were not able to take their medication as prescribed – if at all – because of costs.71

The multi-payer Canadian system for prescription drug coverage is highly in-efficient. With 24 separate companies each negotiating with large pharma-ceutical companies for each individ-ual drug price, private insurers have limited leverage with which to negoti-ate costs.72 In private plans, costly in-creases are passed on to beneficiaries through higher premiums, as private insurers do not negotiate drug prices with the pharmaceutical industry. The premiums for private drug insurance plans for Canadian companies contin-ue to increase at a faster rate than drug costs. This is because most private drug plans are managed by issuance compa-

nies, which are normally compensated by a percentage of drug costs. Private insurers cover over $10 billion in pre-scription drug costs in Canada.73 The fi-nancial incentives for private plans do not encourage stemming the growing costs, but rather increasing them.74 To put it another way, the goal is not cost containment or improved health out-comes, but rather the maximization of profit.75 As a result there is growing gap between what Canadians pay in premiums and what they are receiving in benefits from private, for-profit in-surance providers. For insured group plans alone:

The percentage of premiums paid as benefits dropped from 92% in 1991 to 74% in 2011. This means that Canadians were paying $3.2 billion more in 2011 than they would have if the ratio between premi-ums and benefits had stayed constant since 1991. As costs increase, private plans aren’t moving to contain costs, but to shift them to workers instead.76

Overall, public plans have remained steady (if ineffective) while private in-surance plans have a steep cost curve. Private insurers in Canada have over-head expenses ten times greater than the public system.77 For example, in 2009, the cost of administration in the public health care system in Canada ac-counted for 3.2 per cent of total spend-ing, while the cost of administering pri-vate insurance programs was 15.1 per cent of private insurance spending.78 In 2011, Canadians paid $6.8 billion more in premiums to for-profit insurance companies than they got in care, rep-resenting an overhead cost of about 23 per cent.79 So nearly one-quarter of money paid to for-profit private plans is spent on administration and to pad profit margins. Yet private plans re-ceive large tax subsidies that cost the federal government (and the public through taxes) over $1.23 billion an-nually. Further subsidies are provided by the provinces.80 It is estimated that $1 billion is spent on duplicative legal, technical and administration of private drug plans.81 At the end of the day, it is patients who lose.

TRADING AWAY OUR HEALTH

The WHO’s 1948 constitution outlines the right to the enjoyment of the high-est attainable standard of physical and mental health as “one of the funda-mental rights of every human being without distinction of race, religion, political belief, economic or social con-dition.”82 The right to health has also been enshrined in Article 25 of the 1948 Universal Declaration of Human Rights, Article 12 of the 1966 Interna-tional Covenant on Economic, Social and Cultural Rights and various other international treaties.83 Yet the human right to health is being undermined by a free trade system that demands end-less profits.84

In the past decade there has been a proliferation of free trade agreements whose patent rights well exceed the intellectual property (IP) provision outlined in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. These agreements, known as “TRIPs-plus,” continue to advance despite the “2001 WTO Doha Decla-ration, which explicitly endorses the right of WTO members to protect public health and promote access to medicines for all.”85 A recent report by the United Nations Secretary-Gen-eral’s High Level Panel on Access to Medicines outlines that “Trade and intellectual property rules were not

developed with the goal of protecting the right to health,” and noted infor-mation that pointed to “a progressive de-prioritization and erosion of human rights in the implementation of intel-lectual property law and policy, both under TRIPS and as a result of recent trade agreements.”86 However, the report falls short of fully condemning trade agreements with TRIPS-plus IP provisions and calling for the revision of these agreements, instead believing the false premise that the right to ac-cess medicines can be resolved within “TRIPS flexibilities” to partially tame, but not dismantle monopolies on med-icine.87 The annex to the report also


highlights that some panel members felt that the panel’s recommendations were not enough and should have been bolder. These members called for TRIPS-plus measures in free trade agreements to be halted, reversed and banned, along with investor-state dis-pute settlement mechanisms.88

These TRIPS-plus agreements, which are negotiated in secret, incrementally increase intellectual property and pat-ent rights for Big Pharma, along with their enforcement (outside of nation-al courts). The UN report outlines that these provisions:

Restrict government ability to regulate pharmaceutical prices and reimbursement mecha-nisms. Such provisions sig-nificantly reduce the scope of measures that national govern-ments can use to pursue public health priorities and fulfill the right to health. Ensuring that future trade agreements do not interfere with policies that guarantee the right to health for all is essential for resolving the incoherence between trade agreements and the human right to health.89,90

The current growth of drug expendi-tures and the erosion of the right to health will only accelerate as the Ca-nadian government attempts to sign international trade deals that further entrench pharmaceutical patents. In a recent House of Commons committee meeting on health, the Assistant Depu-ty Health Minister admitted that “High prescription drug costs will rise under pending free trade agreements.”91It is estimated that the Trans-Pacific Part-nership (TPP) will add more than $800 million to prescription drug costs in Canada.92 Other trade deals, like the Canada-European Union Comprehen-sive Economic and Trade Agreement (CETA), will increase costs by an ad-

ditional $850 million to $1.65 billion annually.93 Depending on whether the TPP or CETA is ratified first, drug costs are expected to rise by between 5 and 12.9 per cent starting in 2023 because of additional patent rights to the phar-maceutical industry.94,95

CETA commits Canada to creating a new system of “patent term resto-ration,” which will delay the entry of generic medicines onto the market by two years. This delay will equate to billions of dollars of profit for the brand name pharmaceutical industry at the expense of Canadians. CETA also locks Canada into longer terms of data protection/exclusivity which makes it more difficult for future Canadian governments to change limits on the length of time a drug has exclusivity in the marketplace. With CETA this could mean that the percentage of drugs having extended market exclusivity jumps from 24 per cent to at least 45 per cent.96 This trade agreement will also allow a new right of appeal un-der the “patent linkage system,” which could add an additional 6 to 18 months to patent life after expiring, further de-laying cheaper generic drugs. The pre-vious federal government, under for-mer Prime Minister Stephen Harper, had pledged to compensate provinc-es for any additional costs. However, there was no compensation promised for individuals or private insurance plans.97

Much of the recent discussion around the TPP and patent rights is in regards to “biologics.” Biologics are a class of medical products that include a wide range of drugs that are made from bi-ological sources. Most of the drugs we are familiar with are chemically syn-thesized and are made up of a relative-ly simple combination of molecules. Biologics are made of giant molecules that are many hundreds of times the size of conventional drug molecules (a molecule of aspirin consists of 21 atoms, whereas a biopharmaceuti-cal molecule might contain anywhere from 2,000 to 25,000 atoms). Biologics can be composed of sugars, proteins, or nucleic acids or complex combi-nations of these substances and are manufactured inside animal cells or micro-organisms such as bacteria.98

Biologics are in the TPP because they represent big money for pharmaceu-tical companies. Biologics offer Big Pharma a greater chance for a “block-buster” drug than chemically synthe-sized drugs. Studies suggest the global market for biologics will reach $386.7 billion by the end of 2019.99 Biologics provided roughly 22 per cent of the Big Pharma companies’ sales in 2013. This percentage is expected to rise to 32 per cent by 2023.100 The further en-trenchment of biologic patents in the TPP is also an attempt to stop Subse-quent Entry Biologics (SEB) from enter-ing the highly profitable market. SEBs – called biosimilars or follow-on bio-logics in other countries – are in some ways “generic” versions of biologics, but biologics are more difficult to copy than conventional drugs. SEBs are typically discounted between 15 and 30 per cent from the cost of the ref-erence drug.101 In comparison, prices for small-molecule generic drugs can be discounted by as much as 80 per cent relative to the patented brands they copy.102 In Canada, biologics are an increasing burden on health care

The Pharmaceutical company – Eli Lilly – is using the ISDS provisions in NAFTA to sue Canada for $500 million.


budgets. In 2010, biologics accounted for more than 14 per cent of the Cana-dian pharmaceutical market and cost the Canadian health care system over $3 billion a year.103 Biologics are ex-pected to grow to approximately 20 per cent of the market over the next decade.104 The biologic drug remicade, for example, cost Ontario $84 million in 2012/2013, equivalent to 4.3 per cent of the Ontario Drug Benefit Plan’s drug budget.105 Across Canada, biologics are the largest cost driver in drug spending and three drugs alone accounted for $1.5 billion in pharmaceutical spend-ing in 2013.106

Long before the public had heard of the TPP, the pharmaceutical industry was actively lobbying on the file. In 2009, lobbying reports in the U.S. showed that “28 organizations filed 59 lobby-ing reports mentioning the then far-off trade agreement. Almost half of those organizations were pharmaceutical companies or associations.”107 In 2015, pharmaceutical companies in the U.S. spent “50 per cent more on lobby-ing than the runner-up industry (insur-ance). That matches long-term trends with Big Pharma spending $3.2 billion on lobbying since 1998 – almost 50 per cent more than the runner-up insur-ance companies.”108 On April 9, 2016, the Obama administration sent a doc-ument to Congress defending the TPP, describing how the TPP will make drug monopolies more common, stronger and longer, and drug prices higher – assuaging Big Pharma that their lobby-ing money was well spent.109

While Canada’s lobby reports are more general then those in the U.S., interna-tional trade was the top lobbying topic for Canada in 2015. International trade was mentioned 1,476 times in Canadi-an lobby communication reports that year, which is 248 more times than the second highest topic.110 The top three topics were international trade, indus-

try and health. All three of these topics encompass the pharmaceutical sector, depending on how the lobbyists chose to report their communications.

Big Pharma uses governments to pro-tect its monopolies and has become dependent on trade agreements as a mechanism to expand its monopoly power. While patent protected drugs only account for 10 per cent of the pre-scription drug market, they constitute over 72 per cent of drug spending. The longer a drug company can extend its monopoly protection, the more profits it can make.111 Beyond biologics provi-sions, these TRIPS-plus trade deals also increase secondary patents (minor changes to existing drugs) that length-en a drug’s market exclusivity. This pro-cess, known as “evergreening,” delays the entry of cheaper generics onto the market, keeping the prices high. Since TRIPS agreements came about, Big Pharma adopted more complex patenting strategies since corporations can now file multiple applications for the same invention to create a set of overlapping patent rights – known as “patent thickets” that may be difficult to negotiate.112 A single drug may now be protected by hundreds of patent families, which can lead to more than 1,000 patents and/or pending patent

applications across multiple coun-tries.113 For example, in 2011 the an-tiretroviral medicine ritonavir, which is used along with other medications to treat HIV/AIDS, was protected by 805 patent families.114

There is also an inherent danger with TRIPS-plus agreements like CETA and the TPP that, in the absence of a com-prehensive “carve-out” of health-re-lated measures, there is a serious risk that pharmaceutical companies will use the investor-state dispute settle-ment (ISDS) mechanism to:

Deter governments from reg-ulating in the public interest, thereby sidestepping domestic law. Currently, the U.S. phar-maceutical company, Eli Lilly, is using the ISDS provisions in NAFTA to sue Canada for $500 million, claiming the decision of the Canadian courts to over-turn patents on two Lilly prod-ucts is illegal under the trade treaty. The TPP investment text does little to curb claims like Eli Lilly’s and may, in fact, make matters worse.115

These trade deals will also undoubt-edly create a policy chill in regards to our governments implementing better public health reforms and policy for fear of lawsuits under ISDS. Some ex-perts in intellectual property and law believe that:

Should Canada decide to es-tablish a national program [for pharmacare], the policy choic-es will not be limited to domes-tic considerations. Instead, the TPP will be waiting to mandate many program requirements, including appeals and recon-sideration of decisions for the benefit of pharmaceutical companies.116

While patent protected drugs only account for 10 per cent of the prescription drug market, they constitute over 72 per cent of drug spending.


A BETTER MODEL, BETTER MEDICINE

While Canadians want to see the fed-eral government fulfill its health care responsibilities, with provincial gov-ernments as working partners, con-cerns remain about costs. Without question, there is public aversion to the government investing new money in pharmacare, despite the huge long-term cost savings pharmacare would bring.117 Canadians are concerned that the cost of a universal pharmacare pro-gram will lead to increased taxes. Anal-ysis shows that the cost to provide the program would likely be an additional $1 billion annually.118 While this cost may seem high, when comparing the program’s cost to the approximately $11.4 billion that could be saved annu-ally with the program in place, a uni-versal pharmacare program with first dollar coverage – drug coverage being paid by a public plan without the public incurring an upfront cost – remains the strongest and most logical option. It is estimated that a universal pharmacare program could lower total spending on prescription drugs by approximately 30 per cent in Canada.119 If Canada had a program as strong as New Zealand’s this figure would rise to $18 billion.120 With-out competitive pricing and a system of population-wide bargaining – which we would have with pharmacare – we pay close to $10 billion more every year for medications. Further, “since subsidies to private plans are rendered unneces-sary under pharmacare, its implemen-tation is essentially free.”121 Or to look at it another way, the Canadian govern-ment and the Department of National Defence have no problems spending $1 billion (or more) on the Small Arms Re-placement Project II; the difference is pharmacare would save lives, not take them.122,123

There are competing models of phar-macare programs that policymakers regularly discuss. Many of their discus-

sions are too narrowly focused on sav-ing money while ignoring the urgent need to improve health outcomes in the Canadian population through a fair, equitable and evidence-based phar-macare program. While fiscal consider-ations are, no doubt, important to the discussion, we need to acknowledge that quality health outcomes should be the compass that guides pharmacare. A universal pharmacare system with “first dollar coverage” (i.e. no co-pay-ments, co-insurance or deductibles for individuals) is politically and fiscally sensible, and would create the highest quality health outcomes. This would also allow more than 2 million Canadi-ans to fill prescriptions that they would not otherwise be able to afford.124 It needs to be highlighted that, “effec-tive prescription drug coverage policy is therefore not about just making sure everyone has some form of insurance coverage. It is about ensuring that ev-ery Canadian has effective drug cover-age – coverage that provides equitable access to necessary care without finan-cial barriers.”125

As with any proposed expenditure and policy change of this magnitude there are large vested interests that want to see the current system maintained for their profit.126 Other possible approach-es – such as a tiered, “some drugs” pro-gram, or catastrophic coverage – are in-adequate options that would still leave in place many barriers for patients be-cause they would only address a por-tion of the cost and not address fun-damental safety issues. For example, under catastrophic drug coverage, if patients fill their prescriptions as need-ed, there are deductibles included that are tantamount to a tax on the sick. It is known that “all needs-based means of paying for prescription drug costs – in-cluding deductibles, co-payments, and risk-rated premiums – are borne dispro-

portionately by those with significant and/or ongoing health needs. This lim-its the financial protection provided to patients and families.”127 Research has shown that co-pays of as little as $2 per prescription can prevent patients from getting needed medications.128 Further, studies show that income-based drug plans – which only cover costs above income-based deductibles – fail to pro-mote access to needed medicines.129

Quebec currently employs a hybrid pri-vate-public drug plan, which is often touted by corporate lobbies as the way forward for pharmacare. But this frag-mented model has done little to im-prove fiscal barriers and contain costs. While Canada has the second-highest per capita costs for prescription drugs in the OECD, Quebec has the highest per capita cost among provinces. A re-cent government report noted that the system remains inequitable, inefficient and unsustainable.130 This plan shifts the costs of the public plan onto private plans, which then pass costs onto indi-vidual beneficiaries. The private plan insurance companies receive tax sub-sidies and indirect subsidies, so they have little interest in containing costs. They cover all new drugs at any cost, even when lower cost alternatives are available.

Universal pharmacare could lower total spending on prescription drugs by approximately 30 per cent in Canada.


CANADIANS ARE DYING BECAUSE THEY CANNOT AFFORD THEIR MEDICATION

The Canada Health Act ensures that:

All Canadians have access to medically necessary physicians’ services and hospital care – including all prescription drugs used in hospital – through uni-versal, comprehensive, public health insurance. This system of universal health coverage in Canada does not extend to medications used in the com-munity.131

With 90 per cent of the pharmaceuti-cal market in Canada in the communi-ty setting outside of our public health care system, inadequate access to necessary medication has led to ad-verse health outcomes and premature deaths.132

The increase in the costs of necessary medication is having a negative impact on the health of the nation. In 2007, Statistics Canada found that 1 in 10 individuals did not take the medica-tions they were prescribed because of costs.133 In 2015, a survey looking at changes over the intervening eight years found that 23 per cent of house-holds did not take their medication as prescribed because of costs.134 Re-gionally, British Columbia, where the government only offers “catastrophic” drug coverage, has the highest rate of

access problems at 29 per cent, fol-lowed by Atlantic Canada at 26 per cent (where provincial plans are limit-ed).135

Studies report that 23 per cent of Ca-nadian families – nearly 1 in 4 – fail to take needed medication due to costs, which has an enormous impact on health. As drug prices continue to rise, “lower income people show high-er non-adherence rates, and rates of non-adherence are shown to rise as costs increase, even with fees as low as $10.”136 Five per cent of Canadian children and adults and 10 per cent of Canadian seniors pay over $3,000 per year for drugs. A catastrophic drug program that only paid for these med-ications would still leave 19 per cent of the households without affordable access.137

Canadians are also dying because they cannot afford their medication. A study found that in Ontario alone, “over 700 diabetic patients under the age of 65 died prematurely each year between 2002 and 2008 because of inequitable access to essential prescription drugs. That is like a plane full of Canadians crashing every year, perhaps every month, while governments refuse to take action because of concerns about costs and politics.”138

The problem of non-adherence to pre-scribed medications occurs in Canada at rates higher than comparable health systems in Europe and Australasia.139 In Canada it is believed that 6.5 per cent of hospital admissions are the result of non-adherence to medications, which costs an estimated $7 billion to $9 bil-lion per year.140 But this says nothing about the personal trauma and health impacts these individuals experience.

A NATIONAL FORMULARY: EVIDENCE, SAFETY, APPROPRIATENESSS, VALUE FOR MONEY

While containing costs and achiev-ing long term medicare sustainability through a universal pharmacare pro-gram would have a positive impact by allowing all Canadians to get the med-ications they need, little is said about drug and patient safety, prescribing ap-propriateness, and our national regula-tors (Health Canada and the Patented Medicine Prices Review Board). In all

of these areas, the pervasive and toxic influence of Big Pharma has created a situation where Canadians are not re-ceiving the quality drug coverage they deserve. Where universal pharmacare can be truly transformative is as a tool to ensure an evidence-based approach is used to achieve the best therapeutic benefits for patients.

The Canadian constitution divides the responsibility for pharmaceutical medication between the federal and provincial levels of government. Cur-rently, the provincial governments are responsible for establishing their public formularies. A large majority of the safety and efficacy information that the provinces ultimately rely on comes from the federal government.

Studies report that 23 per cent of Canadian families – nearly 1 in 4 – fail to take needed medication due to costs.


Moreover, much of the data comes from what Big Pharma submits to Health Canada to obtain approval for its drugs. Provinces do not have full ac-cess to the clinical trial data from drug companies because Health Canada be-lieves the data is proprietary informa-tion and, as a result, does not release all the information needed to assess if a medication should be listed in a pro-vincial plan. Even under Canada’s Ac-cess to Information Act, Health Canada will not release the full data unless the drug company involved agrees.141

Universal pharmacare does not mean that every drug should be covered under the program. What is needed is a national formulary (a list of ev-idence-based drugs that have been approved), which is one of the most important elements currently missing in Canada’s health system. This means a higher standard of evidence is need-ed. A new national agency is needed to provide transparency and accountabil-ity in the process of determining what drugs are covered based on appropri-ateness, safety, value for money, and objective evidence-based medical re-views. Other nations have similar agen-cies, such as the NPS MedicineWise in Australia’s national strategy for quality use of medicines to ensure patients re-ceive the best medication option.142

This agency would provide a publicly accountable body (with representa-tion from the public, prescribers and governments), predictable funding and transparency to increase Canada’s purchasing power through the best possible formulary. Currently, Canada has no national strategy to make safe and appropriate prescription drug use part of Canadian health care culture. Patients and prescribers have limited access to unbiased information, which creates disparities and confusion. A single, evidence-based formulary would encourage the appropriate use

of medicines while considering thera-peutic value to patients.143

Research shows that around 80 per cent of new drugs entering the market today do not have an increased thera-peutic benefit to patients over existing, cheaper drugs.144 At the same time, it is estimated that “private drug plans waste $5.3 billion in reimbursements for drugs that do not provide any addi-tional therapeutic benefits compared to existing formulations. This amount represents 56 per cent of total mon-ey spent by private drug plans.”145 This becomes increasingly significant when combined with the fact that Canadians will spend around $30 billion on pre-scription medication in 2016.

Fifteen per cent of Canadians are aged 65 and over (classified as senior citi-zens).146 Eighty-five per cent of seniors take at least one prescription drug and those over 80, on average, take five.147 Sadly, the crisis of polypharmacy – the use of four or more medications by a patient – for Canadian seniors means that nearly 70 per cent of all seniors take five or more different drugs and almost 10 per cent take 15 or more.148 Polypharmacy has been associated with functional decline, cognitive im-pairment, falls, negative drug interac-tions, adverse drug effects, prescribing cascade and many other serious health issues for seniors. At the same time, it drives up health care costs.149,150

When one-third of doctors visits lead to a prescription, seniors are often not aware that the use of multiple medica-

tions increases their chances of ending up in the emergency department or being admitted to hospital. An Ontario study found that “each additional med-ication is associated with a 2-3 percent increase in the likelihood of hospital-ization and a 3-4 percent increase in the likelihood of an ED [emergency de-partment] visit.”151 In 2013:

More than one in three Cana-dians (37 per cent) over age 65 filled at least one prescription for medicines believed to pose unnecessary risks for older adults – at a total direct cost of over $400 million for prescrip-tions alone... It is estimated that one in six hospitalizations in Canada could be prevented if prescription drugs were pre-scribed and used more appro-priately.152

While the lack of prescribing appro-priateness by physicians is not limited to seniors, they represent a clear case where we need to do more to ensure safe use and therapeutic value.

It is estimated that one in six hospitalizations in Canada could be prevented if prescription drugs were prescribed and used more appropriately.


BIG PHARMA’S INFLUENCE ON PUBLIC HEALTH PROFESSIONALS

One of the distressing facts about the medical profession in Canada is that Big Pharma has a dangerous influence over physician prescribing habits. It is estimated that drug companies spend a minimum of $60,000 per doctor per year on drug promotion.153 Pharma-ceutical sales representatives (PSRs) “visit doctors’ offices, providing wall charts and free samples, plus paying for doctors to attend conferences and give papers. It also means advertizing drugs in medical journals and to the public at large. Nothing about this process is objective.”154 In 2008, 92 per cent of doctors still accepted visits from PSRs and 88 per cent saw them because they believed that they re-ceived relevant information.155

A study that compared prescribing habits of primary care physicians in Montreal, Vancouver, Sacramento and Toulouse who were visited by PSRs, who are often the first informa-tion source on new drugs for doctors in Canada, found that:

Information on health benefits was provided twice as often as information on harm, with not a single harmful effect men-tioned in over half of promo-tions in the three North Amer-ican sites... Similarly, serious harm was rarely mentioned for drugs with boxed warnings or subject to recent safety adviso-ries... Nevertheless, physicians judged the quality of scientific information to be good or excellent in 901 (54 per cent) of promotions, and indicated readiness to prescribe 64 per cent of the time.156

The influence of Big Pharma marketing is not limited to doctors’ offices. A re-cent study, “comparing general med-icine journals in Canada, the United

Kingdom and the United States found five times the volume of pharmaceu-tical advertizing in the two Canadian journals – The Canadian Medical As-sociation Journal and Canadian Family Physician – compared with their coun-terparts.”157,158

There is a documented “gift relation-ship” between physicians and Big Pharma. The ultimate goal is “not simply to promote a product. Rather, the goal is to build trust – sometimes, even friendship – so that physicians are more likely to accept what they’re told about the safety and effectiveness of not just one drug, but the next one too.”159 Investigations have found in Canada that beyond PSR visits:

Drug companies routinely host and bankroll dinners at upscale restaurants as training for family doctors. Speakers, paid by the drug company, give pre-sentations and field questions from doctors, who get pro-fessional credits for attending the event. At more than one dinner it was found the speaker recommended a medication for certain treatments – the medication made by the same company that organized the event, paid for the wine and food and paid the doctor giving the talk.160

In Ontario alone there were more the 500 industry-sponsored events that physicians could to attend to keep their licence in good standing. It was revealed roughly 70 per cent of the events listed on the College of Family Physicians of Canada’s website – the organization responsible for accredit-ing continuing medical education and certifying all family doctors in Cana-da – were put on by drug companies, sometimes indirectly through hired

communication firms.161 At the same time, it has been documented that the Canadian Medical Association (CMA) took $780,000 from Pfizer Canada to fund its new continuing medical education program (two Pfizer staff members also sat on an administrative board of the CMA during this time).162 While other professional accrediting associations – from accounting to law – say no to industry funding in this manner, the College of Family Phy-sicians of Canada continues to take “drug-industry money to pay for its ed-ucation programs despite commission-ing a report on Big Pharma’s influence, which it then kept under wraps for two years.”163 The college still “refuses to divulge an analysis of exactly how much corporate funding its education-al programs receive.”164 By influenc-ing how doctors prescribe medication through the sponsorship of their edu-cation and professional development, Big Pharma has a perfect avenue to in-crease its sales. Not surprisingly, these programs influence prescribing habits, lead to a narrower range of topics dis-cussed and favour the pharmaceutical sponsors’ product.165

No other country in the world consumes, on a per-capita basis, more prescription opioids than Canada. Approximately 410,000 Canadians reported abusing prescription drugs.


It should also be noted that doctors are not alone in taking money and gifts from Big Pharma. The choice to substi-tute a brand product with a generic is up to the pharmacist. However:

Pharmacies reap the bene-fits of this price competition, rather than patients. Generic drug manufacturers therefore compete among themselves by trying to influence pharma-cies through large rebates and gifts. Although these gifts and rebates normally go against pharmacists’ code of ethics, it is estimated that 85 per cent of pharmacies accept such gifts, thus creating an institutional-ized form of corruption in the pharmacy sector.166

These inducements mean that in 2009, a medium-sized pharmacy in Canada received $240,000 a year on average in unethical revenues.167 A recent feder-al probe into retail pharmacists found more than 1,000 failed to pay taxes for unreported benefits and incentives from generic drug companies, which is more than $58 million in hidden in-come.168 A universal pharmacare plan would eliminate this system of institu-tionalized corruption and could save at least 39 per cent on generic drugs sold in pharmacies.169

The current opioid epidemic serves as a recent example of the inherent danger we face without an evidence-based na-tional formulary, and how Big Pharma can create a dangerous public health crisis in the name of profit.170,171,172,173 In the late 1990s and early 2000s, Big Pharma spent hundreds of millions of dollars to ‘educate’ doctors on the use of opioids for treating chronic pain over the long term, and stated the risk of addiction was less than one per cent. Yet this claim had little to no scientific backing, and real world addiction rates were found to be as high as between

8 to 12 per cent.174,175 Purdue Pharma, the company behind oxycontin, “has a yearly promotional budget of $14-mil-lion in Canada for its painkilling prod-ucts... Virtually all those resources are targeted at the country’s physicians, the gatekeepers who make or break any new medication.”176 In the U.S., Purdue was found guilty of misleading doctors about the addictiveness of the drugs, including using fake scientific charts.177,178 From 2006 to 2015, mak-ers of opioid painkillers in the U.S. out-spent the U.S. gun lobby on lobbying and campaign contribution by a ratio of eight to one.179

A Purdue-funded speaker was one of the teachers in the University of To-ronto’s inter-faculty pain curriculum course. For years students received free copies of Pain Management, a textbook paid for and copyrighted by Purdue.180 By 2007, companies selling opioid analgesics had given more than $500,000 in funding to the universi-ty.181 It was found that “the course material contained information that aligned with the interests of these companies by minimizing opioid-re-lated harms relative to those of other analgesics, overstating the evidence for their effectiveness, and in at least one instance, provided a potentially dangerous characterization of the po-tency of a commonly used opioid... Opioid prescriptions and opioid-re-lated deaths both also rose in Ontar-io during the period medical students were exposed to this information in an industry-supported lecture series.”182 Further, there is a parallel between the coercive marketing techniques and tac-tics used to promote oxycontin in the U.S. and Canada. A Newfoundland and Labrador Government Task Force on oxycontin concluded that Canadians are very much subjected to U.S. pro-motional material through U.S. media and are influenced by it.183 In Nova Sco-tia, a class action lawsuit claimed that

the marketing strategies and tactics for oxycontin were the same as those em-ployed in the United States.184

This year, after 200 opioid-related deaths, British Columbia’s chief med-ical officer of health declared B.C.’s first ever public health emergency.185 In Alberta, deaths from fentanyl have increased by 4,500 per cent over the last five years. Fentanyl is a more po-tent analgesic than oxycontin, and has been around since the 1950s. The cur-rent rise in fentanyl abuse, however, correlates with the increase in opioid prescriptions like oxycontin.186 In On-tario one out of eight deaths among young adults is attributable to opioids. Opioids were the third leading cause of accidental death in Ontario in 2014, and in 2013 12 per cent of Ontario high school students reported having used prescription opioids for non-medical purposes.187,188 No other country in the world consumes, on a per-capita basis, more prescription opioids than Can-ada. In 2015, doctors wrote enough prescriptions for one in every two Ca-nadians, totalling between 19.1 million to 22 million prescriptions, depending on the source.189,190,191

Overall, the federal government has recognized that “prescription drug abuse is a growing public health and safety problem in Canada, particular-ly among youth. In the 2012 Canadi-an Alcohol and Drug Use Monitoring Survey, approximately 410,000 Cana-dians reported abusing prescription drugs like opioid pain relievers.”192 With a universal pharmacare program in place, these figures could be signifi-cantly lower. Such a program would be able to provide a coordinated national approach to the safety and appropri-ate prescribing of medications while removing Big Pharma’s sales reps from doctors’ offices.


FLAWED CLINICAL TRIALS: WE NEED BETTER EVIDENCE

More medicine does not necessarily mean better medicine. We need to “re-frame the ‘pharmacare question’ from one of simple access to one of access to what, exactly. Our gaze must turn upstream to the producers of pharma-ceutical knowledge – companies that have long insisted that unpublished information about drug safety and ef-fectiveness must be held in confidence by the regulator.”193 There is a large body of evidence that shows that Big Pharma’s clinical trials for new medica-tions have created an epidemic of junk science, switched outcomes, and ghost writing/authorship. It has been doc-umented that industry-sponsored tri-als are more likely to report positive results than independent studies, and that researchers with financial ties to manufacturers are more likely to express opinions that are favourable to Big Pharma.194,195 This year, two of Canada’s major publishing houses for medical journals were bought up by an international publisher that is be-ing sued by the U.S. government to stop it from printing what amounts to junk science for profit.196 A new research project on clinical trial out-comes found that in five of the most prestigious medical journals, 58 out of 67 articles examined regarding clinical trials had “switched outcomes,” mean-ing that unscrupulous researchers go on fishing expeditions to prove what-ever result they want.197,198 This ma-nipulation of science for positive trial results undermines the safety and in-tegrity of drug data, taints the integrity of published trials and increases the risk of exaggerated or even false-pos-itive findings (leading to what is called the “replication crisis” in science).199

Even the clinical practice guidelines for doctors, which are supposed to provide the best clinical evidence and guide doctors’ decisions, have been in-

fected by Big Pharma’s predatory influ-ence. In Canada, the Canadian Medical Association distributes these guide-lines, and a large majority of the guide-lines’ authors have financial ties to Big Pharma. In a study of 350 authors from 28 of the written guidelines, 75 per cent of the documents had at least one author tied to drug companies. In 21.4 per cent of the guidelines, all au-thors had a financial conflict of interest with drug companies. Additionally, in 28.6 per cent of the guidelines more than half of the authors disclosed fi-nancial conflicts of interest with the manufacturers of the drugs that they recommended.200

Further, Big Pharma has hijacked ev-idence-based medicine through the process of “ghost authorship” and “ghost management” of published clinical trials to produce market-based medicine.201 The commercialization of medical information, and the pro-tection of that information as propri-etary, has led to the privatization and commodification of science in ways that most people don’t realize.202 It has become “standard practice for phar-maceutical companies to pay medical communication companies to write articles (based on industry-designed studies), for academic physicians to be paid to essentially sign off on the articles, and then for communica-tion companies to place the articles in prestigious medical journals.”203 By controlling the process of research,

writing and publication of these arti-cles through “ghost management,” this system allows the industry to manage the literature in ways that best serves its interests (profits). To this day, ghost authorship and management remains widespread in industry-financed med-ical journal literature, where those in-volved answer to their paymasters be-fore ethics and evidence.204

In the past two decades Big Pharma companies “have developed systems that treat knowledge as a resource to be carefully developed and used to affect the opinions of research-ers and practitioners. Publication of pharmaceutical company-sponsored research in medical journals, and its presentation at conferences and meet-ings, is now governed by ‘publication plans.’”205 Research and clinical trials have become marketing tools to pro-mote the companies’ message re-garding a drug through publications with positive trial results in prominent journals. It is estimated that “approx-imately 40 per cent of journal reports of clinical trials of new drugs (and, more anecdotally, perhaps a higher percentage of meeting presentations on clinical trials) are ghost managed through to publication.”206 The lack of disclosure and the industry corruption of clinical trials have resulted in phy-sicians being misinformed, which has led to patients’ deaths. The approval of Vioxx is one such case where “pa-tients are not merely put at risk by the way ghost management uses medi-cal research for marketing purposes: they are actually harmed. Not only does ghost-managed research put tri-al participants at risk, it threatens the health of millions of patients who take drugs that might otherwise not be pre-scribed.”207

Health knowledge is largely produced by a group of Big Pharma interests

More medicine does not necessarily mean better medicine.


that shapes the medical discourse and prescribing habits of physicians, and ultimately has an effect on the patient. Medical science relies on the percep-tion that it produces objective and evi-dence-based knowledge that is insulat-ed from subjective analysis. Physicians relay this flawed knowledge and rely on the same biomedical authority – which patients are expected to accept passively – as free from the vested in-terests of drug companies. This knowl-edge is then further modified through the “biomediatization” of information, where health news is reported to re-inforce the neoliberal ideology of con-sumer choice and individual patient re-sponsibility.208 This ideology projects “a utopian world in which medical science and biomedical institutions serve the consumer by producing abundant in-formation and choices, while the mar-ket serves the cause of public health,

as consumers’ responsible choices lead to healthy lifestyles.”209 In other words, through Big Pharma’s management of knowledge, the patient is now an indi-vidual consumer who is offered infor-mation they are told is unbiased and objective. The information presented serves the profits of the pharmaceuti-cal industry each step of the way.

This is not to say that there is not a critical and vital place for clinical trials and medical literature. What we need is a universal pharmacare program with a new national agency to create an evidence-based national formulary that is independent from Big Pharma’s influence. The agency must ensure medicines are appropriate and gen-erate greater benefits than harms for patients. This would include a rigorous regulatory review before the medicines come to market and monitoring after-

wards, along with public accountability. In pharmaceutical research:

A wholesale rethink of the in-centives, criteria, and processes for rewarding and carrying out drug research is needed. We need to hit the reset button so that universities are not in the business of recklessly pro-moting research and funding support for investigator-led and controlled drug trials, and essential groups like Cochrane Canada is restored.210

Beyond better medicine, universal pharmacare represents a challenge to self-interest and individualism that characterizes the current system. Only collectively can the fundamental social right to health and medicine be actu-alized.

ENHANCED PRICE CONTROLS

Once a drug receives a patent and is marketed in Canada, it falls under the jurisdiction of the Patented Medicine Prices Review Board (PMPRB), the quasi-judicial federal body that ensure prices are not excessive. The increased negotiating power that would come with universal pharmacare would ne-cessitate a reframing of the PMPRB, or the creation of a new organization.

Unfortunately, the current limit on the allowable price for a particular drug is set at the median price charged for that drug in seven comparator coun-tries (France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the U.S.), which have some of the highest drug costs in the world.211 Us-ing this group of countries allows Big Pharma to charge shamefully expen-sive prices for drugs in Canada. Four of the countries – the U.S., Switzerland, Sweden and Germany – have the most expensive brand-name prices due to

their systems, which means that every year Canada is automatically the coun-try that ranks third or fourth highest in terms of brand name drugs. It has been estimated that moving down a few spots on this list – from fourth to seventh – Canadians could save more than $1.4 billion or more.212 Further, “Canada has been losing ground to the seven countries, including the United States and France, against which the PMPRB compares drug prices to ascer-tain a reasonable cost. Over the past decade, patented drug prices in Can-ada have gone from third-lowest to third-highest among those countries,” and, “the PMPRB bears part of the blame. We are paying almost 50 per cent more.”213

Setting Canadian prices based on what a selection of other countries allow makes the flawed assumption that these countries have accurate-ly priced their medications. Further,

pharmaceutical companies tend to introduce new drugs into the Ameri-can and German markets first because of the limited price controls.214 These prices then become the benchmark for other countries. There are multi-ple other models that could be used or adapted for the Canadian situation, like that of New Zealand. Alternatively, the PMPRB could use countries which more closely mirror Canada, like Aus-tralia, New Zealand or Norway, for comparison. The therapeutic value of new drugs should also be re-examined periodically after their introduction to accurately determine if the costs are warranted. Lastly, the mandate of the PMPRB only extends to patented drugs, so in the case of old and off-pat-ent orphan drugs essential to many pa-tients – such as daraprim and trientine – where Big Pharma greatly increased their prices, there is not sufficient price control. The PMPRB’s mandate needs to be reworked.215


HEALTH CANADA AND BIG PHARMA

Health Canada’s current mandate is to provide access to safe pharmaceuti-cals, but it does not look at effective-ness, costs or how pharmaceuticals compare to other products on the mar-ket. While there is a clear understand-ing of how enforcement decisions are made by the Food and Drug Adminis-tration (FDA) in the U.S., in Canada we do not have a full understanding of the secretive processes that are followed for approvals or enforcement.216 This leaves the public on the outside look-ing in. Big Pharma, in comparison, has the advantage of working on the inside with Health Canada to game the sys-tem.

Importantly, a universal pharmacare program would be an opportunity to improve Health Canada’s lack of transparency, reduce conflicts of inter-est, change approvals processes and address the dismal enforcement of regulations. Despite Health Canada’s mandate, we continue to have unsafe prescribing and inadequate enforce-ment of drug safety regulations. Mean-while, adverse drug reactions continue to be a leading cause of death in Cana-da.217 The lack of “pharmacovigilance” (activities to detect, assess, under-stand, and prevent adverse drug ef-fects and drug-related problems) mat-ters significantly to health outcomes for Canadians.218 Health Canada must begin to properly regulate Big Phar-ma and its marketing activities. This means ending industry self-regulation for promotion of medicines and apply-ing more stringent rules for conflicts of

interest at Canadian teaching hospi-tals and universities. This would help to ensure future doctors and health professionals are trained based on the best available evidence rather than Big Pharma’s commercial influences.219 Further, “legislated disclosure of finan-cial ties between health professionals and the pharmaceutical industry, as is now done in the U.S., would increase transparency and help to mitigate the effects of conflicts of interest of prac-ticing health professionals.”220

The health and pharmaceutical sectors share structural issues that make them susceptible to corruption and require stringent governance structures. A re-cent report by Transparency Interna-tional highlighted that:

Public medicine procurement is even more vulnerable to corruption than contracting in other services given that medicine volumes are typi-cally large and the contracts are usually quite lucrative... Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.221

There is a long history of clientelism between Health Canada and Big Phar-ma. Government reports have even indicated that Health Canada serves

in an advisory capacity to Big Pharma, the very industry it is expected to regu-late. Where is the accountability when the regulator also acts as an enabler to drug companies applying for licenc-es?222 This conflict of interest increased in 1994 when Health Canada began re-ceiving funding through user fees from the drug industry for reviewing its drug applications (previously funding to op-erate our drug regulatory system came from parliamentary appropriations, i.e. tax dollars). With this new cost re-covery model, in 1994, pharmaceutical companies paid $143,800 to have a new drug application reviewed and by 2014 that amount had risen to $322,056.223 As of 2015, cost recovery was expected to provide about half of the operating budget for the various drug programs of Health Canada. At other times this has been as high as 70 per cent.224,225 Because of this outrageous conflict of interest, it is no surprise that numerous Health Canada documents prioritize Big Pharma’s profit-based goals to get its drugs to market quickly over health protection and safety. Beyond more hasty reviews, Health Canada created two mechanisms to get drugs to mar-ket even faster: priority approvals and the Notice of Compliance with condi-tions (NOC/c). For Health Canada, in-novation means meeting Big Pharma’s agenda of more drugs on the market as fast as possible. Further, there is no requirement in the Food and Drug Reg-ulations that sets a standard as to how effective a new drug has to be.

The threshold for drug approval re-mains low in Canada as “a drug does not have to be better than an existing drug to be approved, but only better than a placebo. Health Canada there-fore approves new brand name drugs that are more expensive than existing drugs, but provide no additional ther-apeutic value, or even less therapeu-

In 1994 Health Canada began receiving funding through user fees from the drug industry for reviewing drug applications.


tic value than drugs already on the market.”226 Many of these new drugs approved are known as ‘me-too’ or ‘follow on’ drugs. They feature a small variation to the original drug, but can create a large profit. For example, the heartburn and ulcer medication nex-ium is a derivative of the older drug prilosec, but the reformulation and repackaging allowed the manufactur-er, AstraZeneca PLC, to prolong its pat-ent and subsequently its profits.227 Yet less is known about the safety of these drugs as they have only been subject to clinical trials in controlled environ-ments, whereas earlier drugs have safety data from previous usage in the general public. At least 85 per cent of the drugs approved by Health Cana-da are these me-too drugs, which are more expensive and of questionable therapeutic advantage.228 In British Columbia it was documented that me-too drugs accounted for 41 per cent of spending in 1996. This jumped to near-ly two-thirds of spending in 2003. This is close to 80 per cent of the increased spending.229

More medicine does not necessarily mean better medicine. There is a dis-turbing trend where Health Canada has been speeding up drug approvals with-out properly assessing patients’ safety. Health Canada has also been weaken-ing drug safety regulations.230 The Au-ditor General reports that Health Can-ada already fails to give timely safety warnings, disclose information on drug trials or address conflicts of interest.231 As Health Canada continues to take large sums of money from Big Pharma, there has been an increasing deregu-lation of clinical trials, drug approvals, safety, promotion and post-market monitoring. More and more trials are now managed by contract research or-ganizations (CROs), which are for-prof-it organizations. The CROs are linked to a rise in ghost authorship, poor transparency, design bias, non-disclo-

sure agreements and little government oversight. It is clear the CROs are inter-ested more in profit than public safety. When 345 new active substances ap-proved between 1997 and 2012 were evaluated for their therapeutic ben-efits by independent organizations, “91 were given priority reviews. Only 52 of them, however, were judged to be therapeutically innovative.”232 It has been found that “drugs having re-ceived a priority review in Canada have a 34 per cent chance of acquiring a se-rious safety warning compared to just under 20 per cent for those given stan-dard reviews.”233

For decades Health Canada has kept important safety information confi-dential at the behest of drug manu-facturers. Post-market surveillance of medications (i.e. monitoring new drugs once they begin to be sold to the public) remains inadequate despite the recent federal bill titled Protecting Canadians from Unsafe Drugs Act, bet-ter known as Vanessa’s Law.234 It has been outlined that:

Although Vanessa’s Law creat-ed new transparency powers, it also legitimated Health Can-ada’s long-standing practice of treating drug safety and effectiveness information as proprietary. The definition of ‘confidential business infor-mation’ in the legislation can accommodate drug safety and effectiveness data provided that the data is not publicly available.235

It seems that Health Canada is con-tinuing, for all intents and purposes, its long-held policy of keeping important safety and effectiveness information confidential at the request of the phar-maceutical industry.

It took one doctor trying to ensure the safety of his pregnant patients approx-

imately three and a half years to get in-formation about diclectin, a drug taken for morning sickness. What he received after years of relentlessly pursuing Health Canada was 359 pages of docu-ments with 212 pages entirely redact-ed, including the sections on “Adverse Events.” After the ordeal the doctor highlighted, “This shows that it is prac-tically impossible for a doctor to get in-formation from Health Canada – even for a drug that is commonly prescribed to pregnant women.”236 In many cases, disclosing this “proprietary” informa-tion would prevent major harm and save lives. In the case of vioxx, which was “approved in 1999 for treating ar-thritis, it was withdrawn from markets in 2004 after thousands are estimat-ed to have suffered cardiac arrest and death. Regulatory officials knew of this risk but kept it secret on the grounds it was company property.”237,238 Health Canada’s lack of transparency regard-ing the effectiveness and safety of drugs leaves both patients and physi-cians misinformed.239 Canadians have “a right to know how safe and effec-tive – or unsafe and ineffective – their medicines are. Anything less will come at a great cost to patient safety and public health.”240

It is not hyperbole to say that in many cases Health Canada serves as a detri-ment to the well-being of the Canadian public. There is an obvious juxtaposi-tion between the goals of public health and the profit seeking motives of Big Pharma. Universal pharmacare would provide an opportunity to revamp the ethically bankrupt policies of accepting uses fees from Big Pharma and an oc-casion to require stronger clinical trials to ensure increased safety while judg-ing the therapeutic value of drugs. This would include releasing all safety data whether a new drug is approved or de-nied. In the case of a safety advisory or withdrawal occurring, Health Canada must stop negotiating wording with


companies and ensure the information is released as expediently as possible. Further, Health Canada should attach robust and enforceable post-market monitoring conditions to drug compa-nies’ product licences. This is especial-ly important for informing formulary evaluations of those interventions as real world evidence about the benefits and harms of a drug accumulates.241 With these changes must come a sin-cere policy change to increase trans-parency.

Lastly, there is no jurisdiction in Cana-da that has the population size or tech-nical capacity to effectively monitor all of the potentially important indicators

of drug safety and effectiveness for patients.242 A universal pharmacare program would have the capacity to develop a pan-Canadian drug safety surveillance program. The monitoring of prescribing practices, medicine safe-ty and health outcomes are currently inadequate. With the management of medicines in isolated systems and plans, we lag behind other countries in the safe and appropriate use of medi-cines. For example, “fewer than one in three doctors in Canada use electronic prescribing tools to help identify prob-lems with drug doses or interactions. In contrast, about 9 in 10 doctors use such systems in New Zealand and the United Kingdom – countries where

public coverage of pharmaceuticals and health care are integrated.”243 With improved monitoring, surveil-lance and prescribing systems, it is estimated that universal pharmacare could “realistically reduce by 50 per cent the existing problems of medicine underuse, overuse, and misuse. This would dramatically improve patient health while reducing costs of medical and hospital care by up to $5 billion per year.”244 Health Canada would play a significant role in providing objective safety and prescribing information to doctors, health care professionals, and the public for drugs used under a na-tional formulary.

CANADIANS CALL FOR PHARMACARE

The health of Canadians “is not a gift; at its best, it can be a fragile accom-plishment attained only through col-lective action.”245 Doubling down on our current patchwork system will only increase the influence of Big Pharma and the inequities Canadians currently face. While vested interests say univer-sal pharmacare is not affordable, this claim is bankrupt as evidence shows it is the key to affordability. The general public in Canada may not all be aware of statistical and technical data out-lined above, but Canadians know med-ications should be a basic human right and not a commodity. The demand for pharmacare remains exceptional-ly high across Canada. A major poll in 2015 found that a striking 91 per cent of Canadians support a universal phar-macare plan.246

The Federation of Canadian Munici-palities, representing 90 per cent of Canada’s municipal population, has endorsed a motion to “call on the federal government to work with the provinces and territories to develop and implement a National Pharmacare

program.”247 Even business groups like the B.C. Chamber of Commerce have recommended that the provincial and federal governments work together to create a universal pharmaceutical program.248 Recent data shows that 90 per cent of businesses in Canada felt generally positive towards the idea of a public pharmacare program.249

Prescription drugs generally repre-sent the largest portion of the cost for employer-provided benefits and are a contentious bargaining issue.250 Uni-versal pharamcare would bring down labour costs in Canada as drug benefits would no longer be a part of labour ne-

gotiations. This would save businesses money, while improving the competi-tiveness of Canada’s labour market. As a result of our medicare, Canada has already been an attractive source for investment from our largest trading partner, the U.S., as our universal sin-gle-payer system offers a competitive advantage for business. Medicare al-ready provides Canadian employers with a competitive advantage equal to approximately $4 an hour. Since phar-maceuticals are the second largest component of health care spending in Canada, a universal, public phar-macare program would add consider-ably to this advantage.251

91 per cent of Canadians support a universal pharmacare plan.


THERE IS NO BETTER TIME THAN NOW

While the Liberals’ 2015 election plat-form and the mandate letter to the Health Minister both make commit-ments to making prescription drugs more affordable in Canada, there are questions regarding the political will to implement a pharmacare pro-gram.252,253 Further, while affordabil-ity is an important factor, improving health outcomes and equity should also be a key feature of the mandate. Governments in Canada should strive for better outcomes for their citizens. In March 2016, the multi-party Stand-ing Committee on Health of the House of Commons began a study on the de-velopment of a national pharmacare program.254 Many other countries have shown that they can achieve better outcomes with a universal pharmacare plan. Adding additional momentum, at the biennial Liberal Party of Canada convention in May of 2016, delegates approved a motion to support a “na-tional-universal pharmacare program as one of its policy priorities,” and “im-plement a national pharmacare plan in place within its first mandate.”255

Unfortunately, like previous Liberal health ministers before her, Minis-ter Jane Philpott indicated that phar-macare is not part of her mandate.256 She fears it would be too costly, stating, “It sounds like it might be expensive and that’s one of the reasons we’re not in the position where we’re about to implement pharmacare.”257 While the health minister is no doubt aware of the inaccuracies in her statement – and that Canadians will end up paying

for this one way or another – there seems to be a lack of political will and courage within the government.

There has never been a better polit-ical moment for pharmacare. There is overlapping interest between pro-vincial and territorial governments, and multiple examples of other com-parable countries that show that bet-ter health outcomes and savings can be achieved through universal phar-macare. Many of the current gov-erning parties in Canada – including parties governing in Ontario, Quebec, and federally –are “Liberal parties that share a common base of political sup-port. This is an exceptionally rare align-ment of Canadian governments – argu-ably one not seen during the history of pharmacare discussions in Canada.”258 While there are many complexities that need to be unpacked, never has there been an alignment like we have today. For pharmacare to become a reality in our federation, Quebec and Ontario need to be on-side. Ontario is currently taking the lead on this issue. Quebec is “also interested in improv-ing their system and might be willing to work with a federal government on im-provements, if conditions are right.”259 Further, the current Health Accord negotiations offer a pragmatic oppor-tunity and realistic tool to implement pharmacare. The Health Accord is a logical place to finally start the process of implementing universal pharmacare with fixed commitments. An issue as significant as the health of Canadians

is too important to be left to the whims of election cycles.

No other policy change and program can have the same kind of positive im-pact on the well-being of Canadians while saving as much as $11 billion annually. The evidence shows that our current system is untenable in the long term and that it cannot control rising drug costs, but we have other viable options. Now, more than ever, we need good pharma, not Big Pharma. Cana-dians are at the breaking point and “cannot continue to quietly pay these outrageous prices for drugs while we cut spending in other areas of health care.” So will our government “take up the challenges represented by our aging population, spiraling drug costs and an increasingly fragmented sys-tem and commit to pharmacare, or will they stay on the current path, fiddling around the edges, without confronting the real issues?”260

The missing ingredient in this is fed-eral leadership and a desire for real change from the government. For too many generations our government has acquiesced to the interests of Big Pharma while Canadians have suffered the consequences. It is only political apathy that is holding us back from fair, equal and universal access to nec-essary medications for all Canadians. Now is the time to commit to a more compassionate society where all Ca-nadians have the right to good health and better medicine. Now is the time for universal pharmacare.

No other policy change and program can have the same kind of positive impact on the well-being of Canadians while saving as much as $11 billion annually.


ENDNOTES1. “The Selection of Essential Medicines.” WHO Policy Perspectives on Medicines, 004. World Health Organization. June 2002.

2. “Medicare Should Cover Prescription Drugs: Editorial.” Toronto Star. 9 June 2015.

3. Morgan, S.G., D. Martin, M.A. Gagnon, B. Mintzes, and J. Lexchin. “Pharmacare 2020: The Future of Drug Coverage in Canada.” Pharmaceutical Policy Research Collaboration. 15 July 2016.

4. Gagnon, Marc-André. “The Economic Case for Universal Pharmacare: Costs and Benefits of Publicly Funded Drug Coverage for all Canadians.” Canadian Centre for Policy Alternatives. 13 September 2010.

5. Morgan S.G., M.A. Gagnon, B. Mintzes, and J. Lexchin. “A Better Prescription: Advice for a National Strategy on Pharmaceutical Policy in Canada.” Healthcare Policy, 12(1): May 2016.

6. Anis, A.H. “Pharmaceutical Policies in Canada: Another Example of Federal-Provincial Discord.” Canadian Medical Association Journal. 162(4): 2000.

7. Boothe, Katherine. “Ideas and the Pace of Change: National Pharmaceutical Insurance in Canada, Australia, and the United Kingdom.” University of Toronto Press. 2015.

8. Salehi, Leila. “National Pharmacare Time to Move Forward.” Canadian Family Physician, 62(7): July 2016.

9. White, Julie. “A National Public Drug Plan for All.” Canadian Health Coalition. May 2016.

10. “National health expenditure trends, 1975-2014.” Canadian Institute for Health Information. 2014.

11. Salehi, Leila.“National Pharmacare Time to Move Forward.” Canadian Family Physician, 62(7): July 2016.

12. “Pharmacy in Canada.” Canadian Pharmacists Association. February 2016.

13. Morgan, S.G., D. Martin, M.A. Gagnon, B. Mintzes, and J. Lexchin. “Pharmacare 2020: The Future of Drug Coverage in Canada.” Pharmaceutical Policy Research Collaboration. 15 July 2016.

14. Pollack, Andrew. “Drug Goes From $13.50 a Tablet to $750, Overnight.” The New York Times. 20 September 2015.

15. Rosenthal, Elisabeth. “The Lesson of EpiPens: Why Drug Prices Spike, Again and Again.” The New York Times. 3 September 2016.

16. Koons, C. and R. Langreth. “How Marketing Turned the EpiPen Into a Billion-Dollar Business.” Bloomberg Business Week. 23 September 2016.

17. “Corruption in the Pharmaceutical Sector: Diagnosing the Challenges.” Transparency International. June, 2016.

18. Gøtzsche, Peter. Deadly Medicines and Organised Crime: How Big Pharma has Corrupted Healthcare. Radcliffe Publishing: 2013.

19. Walker, Joseph. “Drugmakers’ Pricing Power Remains Strong.” Wall Street Journal. 14 July 2016.

20. Ibid.

21. Humer, Caroline. “Exclusive: Makers Took Big Price Increases on Widely Used U.S. Drugs.” Reuters. 5 April 2016.

22. Johnson, Carolyn Y. “The contradictory reasons cancer-drug prices are going up.” The Washington Post. 2 May 2016

23. Dusetzina, Stacie B., “Drug Pricing Trends for Orally Administered Anticancer Medications Reimbursed by Commercial Health Plans, 2000-2014.” JAMA Oncology, 2(7): July 2016.

24. “Working Together for Change: Ontario Public Drug Programs Annual Report 2014-2015.” Government of Ontario. 31 March 2015.

25. Roy, Victor and Lawrence King. “Betting on hepatitis C: how financial speculation in drug development influences access to medicines.” BMJ, 354:i3718: 2016.

26. Patented Medicine Prices Review Board. “Cost Pressure of the New Hepatitis C Drugs in Canada.” Government of Canada. 13 April 2016.

27. Brennan, H., A. Kapczynski, C.H. Monahan, and Z. Rizvi. “A Prescription for Excessive Drug Pricing: Leveraging Government Patent Use for Health.” Yale Journal of Law & Technology (275): 2016.

28. Kesselheim A, J. Avorn, and A. Sarpatwari. “The High Cost of Prescription Drugs in the United States Origins and Prospects for Reform.” Journal of the American Medical Association, 316(8): 2016.

29. Walker, Joseph. “Drugmakers’ Pricing Power Remains Strong.” Wall Street Journal. 14 July 2016.

30. “Lives on the Edge: Time to Align Medical Research and Development with People’s Health Needs.” Médecins Sans Frontières. May 2016.

31. Morgan, S.G., D. Martin, M.A. Gagnon, B. Mintzes, J.R. Daw, and J. Lexchin. “Pharmacare 2020: The future of drug coverage in Canada.” Pharmaceutical Policy Research Collaboration. 15 July 2016.

32. Ibid.

33. “CLHIA Report on Prescription Drug Policy: Ensuring the Accessibility, Affordability and Sustainability of Prescription Drugs in Canada.” Canadian Life and Health Insurance Association Inc. 2013.

34. Dutt, Monika. “Affordable Access to Medicines A Prescription for Canada.” Canadian Centre for Policy Alternatives. December 2014.


35. “Annual Report 2014.” Patented Medicine Price Review Board. 16 November 2015.

36. “Evidence Wednesday, April 13, 2016.” House of Commons Standing Committee on Health. 13 April 2016.


38. “Generics360 – Generic Drugs in Canada.” Patented Medicine Price Review Board. February 2016.

39. Attaran, Amir. “Canada Is Needlessly Bleeding Money on Generic Drugs.” Toronto Star. 17 February 2016.

40. “Canadian Drug Price Gouging for Generics Called ‘Hard to Celebrate’.” CBC News. 9 February 2016.

41. Attaran, Ami. “Canada Is Needlessly Bleeding Money on Generic Drugs.” Toronto Star. 17 February 2016.




45. Hebert, Guillaume. “The pharmaceutical industry in Québec: time for assessment.” Canadian Centre for Policy Alternative. 13 June, 2012.


47. Flood, Colleen. “Remarks to the House of Commons’ Standing Committee on Health: Development of a National Pharmacare Program.” University of Ottawa Centre for Health Law, Policy & Ethics. 26 September 2016.

48. Church, Elizabeth. “Canada among Top Pharmaceutical Spenders on OECD List.” The Globe and Mail. 4 November 2015.

49. Picard, André. “Action, not excuses, on drug coverage.” The Globe and Mail. 6 April 2011.

50. Demers, V., M. Melo, C. Jackevicius, J. Cox, D. Kalavrouziotis, S. Rinfret, et. al. “Comparison of provincial prescription drug plans and the impact on patients’ annu-al drug expenditures.” Canadian Medical Association Journal, 178(4): 2008.

51. Mercer Canada Limited. “Cost Trends in Health Benefits for Ontario Businesses: Analysis for Discussion. Commissioned by the Ontario Chamber of Commerce for Release at the Ontario Economic Summit.” 17 November 2011.

52. “Expenditure on Drugs by Type, by Source of Finance, Canada, 1985-2015.” Canadian Institute for Health Information. 2013.

53. “Report Card: Evaluating workplace supports for health management.” 2016 Sanofi Canada Healthcare Survey. 13 June 2016.

54. Harris, Lauren. “Healthy Outcomes: Getting a better handle on chronic disease.” Benefits Canada. 1 September 2016.

55. Morgan, Steve and Danielle Martin. “Morgan & Martin: Pharmacare: It’s Good for Business.” National Post.15 April 2015.

56. Butler, Don. “Skyrocketing Costs Make Canada’s Private Drug Plans Unsustainable, Insurance Exec Tells Pharmacare Panel.” National Post. 27 May 2013.

57. Welds, Karen. “Drug plan trends report: How drug plans are addressing skyrocketing costs.” Benefits Canada. 18 March 2016.

58. Gang, Yaelle. “Employers urged to take more active role in controlling drug costs.” Benefits Canada. 15 June 2016.

59. Welds, Karen. “Drug plan trends report: How drug plans are addressing skyrocketing costs.” Benefits Canada. 18 March 2016.

60. Morgan, Steve and Danielle Martin. “Morgan & Martin: Pharmacare: It’s Good for Business.” National Post. 15 April 2015.

61. “Pan Canadian Drugs Negotiations Report.” Pan-Canadian Pharmaceutical Alliance. 22 March 22, 2014.

62. Ibid.

63. White, Julie. “A National Public Drug Plan For All.” Canadian Health Coalition. May 2016.

64. “Prescription drug access and affordability an issue for nearly a quarter of all Canadian households.” Angus Reid Institute. 15 July 2015.

65. “Measuring Up A yearly report on how Ontario’s health system is performing.” Government of Ontario. October 2016.

66. Canadian Union of Public Employees. “Submission to the House of Commons Standing Committee on Health Development of a National Pharmacare Program.” September 2016.

67. Snyder, Jo. “PharmaCare: Decreasing disparity between rich and poor.” Wellesley Institute. 29 July 2015.

68. Barnes, Steve and Laure Anderson. “Low Earnings, Unfilled Prescriptions: Employer-Provided Health Benefit Coverage in Canada.” Wellesley Institute. 2015.

69. Foster, Melisa. “Pharmacare: Why Millennials Should Pay Attention.” Healthy Debate. 3 August 2016.

70. “Canadians living pay cheque to pay cheque, challenged by debt and economy, payroll survey finds.” Canadian Payroll Association. 7 September 2016.

71. “Prescription drug access and affordability an issue for nearly a quarter of all Canadian households.” Angus Reid Institute. 15 July 2015.



73. Morgan S. and K. Booth. “Universal prescription drug coverage in Canada: Long-promised yet undelivered.” Healthcare Management Forum, 1(8), October 2016.

74. Silversides, Ann. “Ontario’s law curbing the cost of generic drugs spark changes.” Canadian Medical Association Journal, 181 (3–4), 4 August 2009.

75. Law M.R., J. Kratzer, and I.A. Dhalla. “The increasing inefficiency of private health insurance in Canada.” Canadian Medical Association Journal, 186(12): March 2014.


77. Ibid.

78. “National Health Expenditure Trends, 1975 to 2012.” Canadian Institute for Health Information, 2012.

79. Law, M.R., J. Kratzer, and I.A. Dhalla. “The increasing inefficiency of private health insurance in Canada.” Canadian Medical Association Journal, 186(12): March 2014.

80. Gagnon, Marc-André. “Pharmacare and Federal Drug Expenditures: A Prescription for Change.” How Ottawa Spends, 2013.


82. “Constitution of the World Health Organziation.” World Health Organization. 7 April 1948.

83. United Nations Secretary-General’s High Level Panel on Access to Medicines. “Promoting Innovation and Access to Health Technologies.” United Nations. 14 September 2016.

84. Chen, Michelle. “Free-Trade Deals Are Making It Much Harder to Fight AIDS: The Trans-Pacific Partnership and its ilk protect profits at the expense of prevention.” The Nation. 19 September 2016.

85. Forman, Lisa and Gillian MacNaughton. “Lessons learned: a framework methodology for human rights impact assessment of intellectual property protections in trade agreements.” Impact Assessment and Project Appraisal, 34(1), 25 March 2016.

86. United Nations Secretary-General’s High Level Panel on Access to Medicines. “Promoting Innovation and Access to Health Technologies.” United Nations. 14 September, 2016.

87. “Health Gap Statement on the Final Report of the UN Secretary-General’s High Level Panel on Access to Medicines.” Health Gap Global Access Project. 14 Sep-tember 2016.

88. United Nations Secretary-General’s High Level Panel on Access to Medicines. “Promoting Innovation and Access to Health Technologies.” United Nations. 14 September, 2016.

89. Ibid.

90. Baker, Brook and Katrina Geddes. “Corporate Power Unbound: Investor-State Arbitration of IP Monopolies on Medicines - Eli Lilly v. Canada and the Trans-Pacific Partnership Agreement.” Journal of Intellectual Property Law, 23(1): October 2015.

91. “Gov’t sees drug costs rising.” Blacklocks Reporter. 19 Apr. 2016.

92. Yussuff, Hasssan. “Letter to Chrystia Freeland Minister of International Trade.” Canadian Labour Congress. 27 January 2016.

93. Beltrame, Julian. “Trade Deal to Increase Cost of Prescription Drugs by up to $1.65-billion, Report Warns.” The Globe and Mail. 30 October 2013.

94. Lexchin, Joel. “Involuntary Medication: The Possible Effects of the Trans-Pacific Partnership on the Cost and Regulation of Medicine in Canada.” Canadian Centre for Policy Alternative. 3 February 2016.

95. Sinclair, Scott. “Major Complications:The TPP and Canadian Health Care.” Canadian Centre for Policy Alternative. 3 February 2016.

96. Hollis, Aidan and Paul Grootendorst. “Drug Market Exclusivity in the EU and Canada: Problems with Norton Rose’s Comparative Analysis.” Canadian Generic Pharmaceutical Association. January 2012.

97. Beltrame, Julian. “Trade deal to increase cost of prescription drugs by up to $1.65-billion, report warns.” The Globe and Mail. 30 October 2013.

98. Otto, Ralf, Alberto Santagostino, and Ulf Schrader. “Rapid growth in biopharma: Challenges and opportunities,” McKinsey and Company. December 2014.

99. Weeks, Carly. “Prescription-drug Spending Holds Steady, but Dollars Spent on Biologics Escalating Quickly: Report.” The Globe and Mail. 28 May 2015.

100. “Going Large.” The Economist. 3 January 2015.

101. Morgan, Steve and Matthew Renwick. “Is Canada Paying Too Much for Generic Biological Drugs?” Healthy Debate. 11 March 2015.

102. Law, Michael and Jillian Kratzer. “The road to competitive generic drug prices in Canada.” Canadian Medical Association Journal, 185(13): 17 September 2013.

103. Canadian Agency for Drugs and Technologies in Health. “Subsequent Entry Biologics – Emerging Trends in Regulatory and Health Technology Assessment Frame-works.” Environmental Scan, Issue 43: 9 January 2014.


104. “Regulatory Landscape: Subsequent Entry Biologics.” The Canadian Generic Pharmaceutical Association. 10 May 2015.

105. Ontario Ministry of Health and Long Term Care. “2012/13 Report Card for the Ontario Drug Benefit Program.” Government of Ontario.

106. Innovation, Science and Economic Development Canada. “Pharmaceutical Industry Profile.” Government of Canada. 19 January 2015.

107. Drutman, Lee. “How Big Pharma (and others) began lobbying on the Trans-Pacific Partnership before you ever heard of it.” Sunlight Foundation. 13 March 2014.

108. Weissman, Robert. “Rx for Outrageous Drug Prices: Heal Our Democracy.” The Huffington Post. 6 April 2016.

109. Love, James. “Obama Administration memo: ‘Background on TPP Biopharma Provisions.’ describes how TPP will raise drug prices.” Knowledge Ecology Interna-tional. 12 April 2016.

110. Vigliotti, Marco. “Hot topics: International trade file tops lobbying in 2015, as groups jockey for influence on TPP, CETA.” Lobby Monitor. 5 February 2016.

111. “Game of Patents – How the US Government and Big Pharma Protect Pharmaceutical Profits.” The Institute for Health and Socio-Economic Policy. 30 September 2016.

112. United Nations Secretary-General’s High Level Panel on Access to Medicines. “Promoting Innovation and Access to Health Technologies.” United Nations. 14 September 2016.

113. European Commission Competition DG. “Pharmaceutical Sector Inquiry Final Report.” 8 July 2009.

114. Landon, I.P. “Patent Landscape Report on Ritonavir.” World Intellectual Property Organization. 28 October 2011.

115. Lexchin, Joel and Deborah Gleeson. “TPP and pharmaceutical regulation in Canada and Australia.” International Journal of Health Services, 11 August 2016.

116. Geist, Michael. “The Trouble With the TPP, Day 33: Setting the Rules for a Future Pharmacare Program.” 18 February 2016.

117. Holliday, Ian. “Most Canadians want government to expand the services it provides, but they don’t want to pay for it.” Angus Reid Institute. 22 August 2016.

118. Morgan, Steve and Danielle Martin. “Morgan & Martin: Pharmacare: It’s Good for Business.” National Post. 15 April 2015.

119. Morgan, S. and K. Booth. “Universal prescription drug coverage in Canada: Long-promised yet undelivered.” Healthcare Management Forum, 1(8), October 2016.

120. Morgan, Steve. “A better prescription: the evidence and politics of pharmaceutical policy in Canada.” Grand Rounds, UBC SSPH Seminar Series. 23 September 2016.

121. Dutt, Monika. “Rx For Drug Benefits.” The Globe and Mail. 28 July 2015.

122. Harris, Paul, et. al. “Canadian Small Arms Demonstration Project.” Defence Research and Development Canada. May 2008.

123. “The evolution of the smart gun.” Defence Research and Development Canada. 9 February 2015.

124. Morgan, S.G., J.R. Daw, and M.R. Law. “Rethinking Pharmacare in Canada.” C.D. Howe Institute, Commentary No. 384. June 2013.


126. Foster, Melisa, and Steve Long. “Pharmacare: Lost in Translation.” Global Public Affairs. July 2016.


128. Goldman, Dana, et. al. “Prescription drug cost sharing: Associations with medication and medical utilization and spending and health.” Journal of the American Medical Association, 298(1): 2007.

129. Morgan, S.G., J.R. Daw, and M.R. Law. “Are Income-Based Public Drug Benefit Programs Fit for an Aging Population?.” Institute for Research on Public Policy. 3 December 2014.

130. Gagnon, Marc-André. “Bring in Pharmacare – but not inefficient Quebec model.” Policy Options. 2 July 2015.

131. Morgan, S.G., M.A. Gagnon, B. Mintzes, and J. Lexchin. “A Better Prescription: Advice for a National Strategy on Pharmaceutical Policy in Canada.” Healthcare Policy, 12(1) May 2016.

132. Ibid.

133. Statistics Canada. “Canadian Community Health Survey - Annual Component (CCHS).” Government of Canada. 17 June 2008.

134. “Prescription Drug Access and Affordability an Issue for Nearly a Quarter of All Canadian Households.” Angus Reid Institute. 15 July 2015.

135. Ibid.

136. Dutt, Monika. “Parliamentary Submission to HESA on Pharmacare.” Canadian Doctors for Medicare. 6 June 2016.


138. Canadian Federation of Nurses Unions. “Summary of CFNU’s Parliamentary Breakfast Filling the Prescription: The case for pharmacare now.” 31 May 2016.


139. Morgan S.G., M.A. Gagnon, B. Mintzes, and J. Lexchin. “A Better Prescription: Advice for a National Strategy on Pharmaceutical Policy in Canada.” Healthcare Policy, 12(1) May 2016.

140. Dutt, Monika. “Parliamentary Submission to HESA on Pharmacare.” Canadian Doctors for Medicare. 6 June 2016.

141. Lexchin J, M. Wiktorowicz, and K. Moscou. “Provincial Drug Plan Officials’ Views of the Canadian Drug Safety System.” Journal of Health Politics, Policy and Law, 38(3): 2013.



144. Gagnon, Marc-André, “Who’s afraid of universal pharmacare?.” Evidence Network, June 2013.

145. Gagnon, Marc-André. “Marc-André Gagnon: The Case for National Pharmacare.” National Post. 10 July 2013.

146. Statistics Canada. “Canada’s population estimates: Age and sex, July 1, 2015.” Government of Canada. 29 September 2015.

147. Simpson, Jeffrey. “Why Not a National Drug Plan for Seniors Similar to CPP?” The Globe and Mail. 5 March 2016.

148. Cassels, Alan. “Prescription Drug Use among Seniors Far Too High.” CBC. 22 May 2016.

149. Maher Jr., R.M., J.T. Hanlton, and E.R. Hajjar. “Clinical Consequences of Polypharmacy in Elderly.” Expert Opinion Drug Safety, 13(1): January 2014.

150. Samoy, L.J., P.J. Zed, K. Wilbur, R.M. Balen, R.B. Abu-Laban, and M. Roberts. “Drug-Related Hospitalizations in a Tertiary Care Internal Medicine Service of a Cana-dian Hospital: A Prospective Study.” Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 26(11): November 2006.

151. Allin, S., D. Rudoler, and A. Laporte. “Does Increased Medication Use among Seniors Increase Risk of Hospitalization and Emergency Department Visits?” Health Services Research. 27 September 2016.


153. Gagnon, Marc-André and Joel Lexchin. “The cost of pushing pills: a new estimate of pharmaceutical promotion expenditures in the United States.” PLoS Medi-cine, 5(1): 2008.


155. Chalkley, P. “Targeting accessible physicians.” Canadian Pharmaceutical Marketing. April 2009.

156. Mintzes, B. et. al. “Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States.” Journal of General Internal Medicine, 28(10): October 2013.

157. Lexchin, Joel and Barbara Mintzes. “The pharmaceutical advertising code should be updated.” Healthy Debate. 10 August 2016.

158. Gettings, Jenner et. al. “Differences in the Volume of Pharmaceutical Advertisements between Print General Medical Journals.” PLoS One, 9(1): 8 January 2014.

159. Herder, Matthew and David Juurlink. “Let the Sun Shine on Doctors’ Ties to Pharma.” Toronto Star. 9 May 2016.

160. McLean, Jesse and David Bruser. “Drug Dinners for Physicians under New National Rules.” Toronto Star. 14 March 2016.

161. Bruser, David, Jesse McLean, and Andrew Bailey. “Drug Companies Wine and Dine Family Physicians.” Toronto Star. 16 February 2016.

162. Weeks, Carly. “Medical Association Takes Heat for Pfizer Funding.” The Globe and Mail. 28 February 2011.

163. Blackwell, Tom. “Family-doctor College Releases Long-secret Report on Big-Pharma Funding, but Refuses to Cut off Money Flow.” National Post. 4 January 2016.

164. Ibid.

165. Bowman, M.A. and D.L. Pearle. “Changes in drug prescribing patterns related to commercial company funding of continuing medical education.” Journal of Con-tinuing Education in the Health Professions, 8(1): January 1988.


167. Silversides, Ann. “Ontario’s law curbing the cost of generic drugs spark changes.” Canadian Medical Association Journal, 181 (3–4), 4 August 2009: E43-E45.

168. Beeby, Dean. “Revenue Canada Probe of Pharmacies Finds $58M in Hidden Income.” CBC. 7 July 2016.


170. Armstrong, David. “Secret trove reveals bold ‘crusade’ to make OxyContin a blockbuster.” STAT News. 22 September 2016.

171. Ryan, H., L. Girion, and S. Glover. “More than 1 million OxyContin pills ended up in the hands of criminals and addicts. What the drugmaker knew.” LA Times. 10 July 2016.

172. Ryan, H., L. Girion, and S. Glover. “‘You Want A Description of Hell? Oxycontin 12-Hour Problem.” LA Times. 5 May 2016.


173. Ryan, Harriet. “Purdue Pharma issues statement on OxyContin report; L.A. Times responds.” LA Times. 6 May 2015.

174. Vowles, Kevin E., et. al. “Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis.” Journal of Pain, (156)4: April 2015

175. Milne, V., J. Tepper, and M. Nolan. “5 ways the health system can curb the opioid epidemic.” Healthy Debate. 22 September 2016.

176. Blackwell, Tom. “The Selling of OxyContin.” National Post. 12 November 2011.


178. Meier, Barry. “In Guilty Plea, OxyContin Maker to Pay $600 Million.” New York Times. 10 May 2007.

179. Whyte, L., G. Mulvihill, and B. Wieder. “Politics of pain: Drugmakers fought state opioid limits amid crisis.” The Centre for Public Integrity. 21 September 2016.


181. Persaud, Navindra. “Questionable content of an industry-supported medical school lecture series: a case study.” Journal of Medical Ethics, 40:6, 2014.

182. Ibid.

183. “OxyContin Task Force: Final Report.” Newfoundland and Labrador Government. 30 June 2004.

184. Lexchin, Joel and Jillian Clare Kohler. “The danger of imperfect regulation: OxyContin use in the United States and Canada.” International Journal of Risk & Safety in Medicine, 23, 2011.

185. Piggott, Thomas and Jia Hu. “Opioid Epidemic Requires National Response.” Toronto Star. 30 April 2016.

186. Bracken, Amber. “A Killer High: How Canada Got Addicted To fentanyl.” The Globe and Mail. 8 April 2016.

187. Brosnahan, Maureen. “Opiate Overdose Deaths Rising across Canada.” CBC. 18 June 2014.

188. “Party Drug ‘Purple Drank’ a Dangerous Mix, Police Say.” CBC. 14 May 2016.

189. Bracken, Amber. “A Killer High: How Canada Got Addicted To fentanyl.” The Globe and Mail. 8 April 2016.


191. Herder, Matthew and David Juurlink. “Let the Sun Shine on Doctors’ Ties to Pharma.” Toronto Star. 9 May 2016.

192. “About prescription drug abuse.” Government of Canada. 14 April 2016.

193. Herder, Matthew. “It’s Time to Think beyond National Pharmacare.” Toronto Star. 8 February 2016.

194. Cosgrove, L., S. Vannoy, B. Mintzes, and A.F. Shaughnessy. “Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation.” Accountability In Research, 23( 5): 2016.

195. Lexchin, Joel. “Economics and industry do not mean ethical conduct in clinical trials.” Journal of Pharmaceutical Policy and Practice, 6(11): 2013.

196. Oved, Marcho Chown. “Canadian medical journals hijacked for junk science.” Toronto Star. 29 September 2016.

197. Goldacre, B., H. Drysdale, A. Powell-Smith, et. al. “The COMPare Trials Project.” www.COMPare-trials.org. 2016.

198. “Clinical Trials: For My next Trick...” The Economist. 26 March 2016.

199. Baker, Monya. “1,500 Scientists Lift the Lid on Reproducibility.” Nature. 28 July 2016.

200. Shnier, A., J. Lexchin, M. Romero, and K. Brown. “Reporting of financial conflicts of interest in clinical practice guidelines: a case study analysis of guidelines from the Canadian Medical Association Infobase.” BMC Health Services Research, 16(383): 15 August 2016.

201. Ioannidis, John P.A. “Evidence-based medicine has been hijacked: a report to David Sackett.” Journal of Clinical Epidemiology, 73: 2016.

202. Rosenberg, Harriet and Adrienne Shnier. “The Conflict of Interest Movement in Medicine, Part 1.” Our Right to Know Network. 9 May 2016.

203. Cosgrove, L., S. Vannoy, B. Mintzes, and A.F. Shaughnessy. “Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation.” Accountability In Research, 23( 5): 2016.

204. Matheson, Alastair. “Ghostwriting: the importance of definition and its place in contemporary drug marketing.” BMJ, 354:i4578: 2016.

205. Sismondo, Sergio and Mathieu Doucet. “Publication Ethics and the Ghost Management of Medical Publication.” Bioethics, 24(6): 2010.

206. Ibid.

207. Ibid.

208. Briggs C.L. and D.C. Hallin. Making Health Public: How News Coverage Is Remaking Media, Medicine, and Contemporary Life. Routledge. 2016.

209. Briggs C.L. and D.C. Hallin. “The Neoliberal Subject and Its Contradictions in News Coverage of Health Issues.” Social Text, 25(4): 2007.




212. Ibid.

213. “Canada’s high drug prices under review.” Canadian Medical Association Journal, 22 August, 2016.

214. “Annexe D: global overview of the pharmaceutical industry.” Office of Fair Trading. 2007.

215. Herder, Matthew. “Pharma Financialized.” Impact Ethics, 25 September 2015.

216. O’Leary, P. “Credible deterrence: FDA and the Park Doctrine in the 21st century.” Journal of Food and Drug Law, 68(2): 2013.

217. “Fact sheet – Expand Medicare: Pharmacare.” Canadian Union of Public Employees. 21 February 2013.

218. Kohler, J.C., K. Moscou, and J. Lexchin. “Drug Safety and Corporate Governance.” Global Health Governance, 8(1), 2013.


220. Boozary, Andrew and Joel Lexchin. “Big Pharma’s Relationship with Your Doctor Needs Some U.S.-style Sunshine.” The Globe and Mail. 26 March 2014.

221. “Corruption in the Pharmaceutical Sector: Diagnosing the Challenges.” Transparency International. June, 2016.

222. Fierlbeck, Katherine. “The blurred roles of our pharmaceutical regulators.” Policy Options, 13 July 2016.

223. Health Canada. “Pharmaceutical submission and application review fees as of April 1, 2014.” Government of Canada. 31 March 2016.

224. Health Canada. “Health Canada’s proposal to parliament for user fees and service standards for human drugs and medical devices program.” Government of Canada. 26 March 2010.

225. Lexchin, Joel. “Drug safety and health Canada.” The International Journal of Risk & Safety in Medicine, 22(1): January 2010.


227. Picard, André. “‘New’ Drugs Too Often Offer Little New.” The Globe and Mail. 17 March 2009.

228. Lexchin, Joel. “Postmarket safety in Canada: are significant therapeutic advances and biologics less safe than other drugs? A cohort study.” BMJ, 4:e004289: 2014.

229. “Increasing Drug Costs: Are we getting good value?” Therapeutics Initiative. 31 July 2006.

230. Lexchin, Joel. Private Profits Versus Public Policy: The Pharmaceutical Industry and The Canadian State. University of Toronto Press, 2016.

231. Auditor General of Canada. “2011 Fall Report. Chapter 4 – Regulating Pharmaceutical Drugs – Health Canada.” Government of Canada. 22 November 2011.

232. Lexchin, Joel. “Health Canada’s Use of its Priority Review Process for New Drugs: A Cohort Study.” BMJ, e006816: 2015.

233. Lexchin, Joel. “New Drugs and Safety: What Happened to New Active Substances Approved in Canada between 1995 and 2010?” Archives of Internal Medi-cine, 172(21): 2012.

234. “Bill C-17: An Act to amend the Food and Drugs Act, Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).” Government of Canada. 6 November, 2014.

235. Herder, Matthew. “Reinstitutionalizing transparency at Health Canada.” Canadian Medical Association Journal, 2015.

236. Bruser, D. and J. McLean. “Health Canada hands over documents but muzzles doctor.” Toronto Star. 14 October 2015.

237. Graham, D.J. et. al. “Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-ste-roidal anti-inflammatory drugs: nested case-control study.” Lancet, 365(9458): February 2005.

238. “Vioxx: lessons for Health Canada and the FDA.” Canadian Medical Association Journal, 172(1): 4 January 2005.

239. Herder, Matthew. “It’s Time For Big Pharma To Open Up About Drug Safety And Effectiveness.” The Huffington Post. 17 February 2016.

240. Herder, M., T. Lemmens, J. Lexchin, L. Mintzes, and T. Jefferson. “Is pharmaceutical transparency in Canada all just talk?” Policy Options, 12 July 2016.



243. Schoen, Cathy and Robin Osborn. “The Commonwealth Fund 2012 International Health Policy Survey of Primary Care Physicians.” Commonwealth Fund. Novem-ber 2012.


245. Butler, M. and M. Barlow. “Foreword To The Third Edition.” Social Determinants of Health Canadian Prespectives. Canadian Scholars Press, 2016

246. “Prescription Drug Access and Affordability an Issue for Nearly a Quarter of All Canadian Households.” Angus Reid Institute. 15 July 2015.

247. “FCM and BC Chamber of Commerce endorse National Pharmacare program.” Lobby Monitor. 10 June 2016.



249. “Pharmacare in Canada.” Aon Hewitt Inc. January 2016.



252. Trudeau, Justin. “Minister of Health Mandate Letter.” Government of Canada. November 2015.

253. “A New Plan for a Strong Middle Class.” Liberal Party of Canada. 2015.

254. Morgan, S. and K. Booth. “Universal prescription drug coverage in Canada: Long-promised yet undelivered.” Healthcare Management Forum, 1(8): October 2016.

255. “Policy Resolution E-09 Pharmacare.” Liberal Party of Canada. May 2016.

256. Duggan, Kyle. “MPs Begin Study on Pharmacare, Warned of High Drug Costs.” iPolitics. 13 April 2016.

257. “Pharmacare Vetoed As Costly.” Blacklocks Reporter. 13 April 2016.

258. Morgan, S. and K. Booth. “Universal prescription drug coverage in Canada: Long-promised yet undelivered.” Healthcare Management Forum, 1(8), October 2016.


260. Silas, Linda. “Canada’s Nurses Push for Bold Vision on Prescription Drugs.” National Newswatch. 19 January 2016.

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